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Author Topic: Torque Wrench/Screwdriver  (Read 5901 times)
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dennis100
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« Reply #30 on: March 12, 2018, 12:23:48 AM »

Model Number 103
Event Date 06/28/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the torque wrench. The end tip of the torque wrench hex shaft, where it inserts into a hex setscrew, was stripped (rounded corners). Product analysis found that based on the actual physical appearance of the torque wrench shaft tip end, the most likely reason for the stripped condition is mechanical damage that occurred as a result of incomplete insertion into a setscrew. In addition, the torque wrench could have been inserted "out of alignment" with the hex-head of a setscrew, resulting in the observed damage. Other than the mentioned observations, no other anomalies were identified. Product analysis on the explanted generator was completed on (b)(6) 2012. Examination of the setscrew verified that the top portion of the hex head was stripped / rounded out by the torque wrench. Damage was also noted on the tip of the torque wrench. Product analysis stated that this condition is mostly likely due to user error in not fully inserting the torque wrench into the hex head of the set screw. Results of diagnostic testing indicated the device was operating properly and communicated properly. Electrical test results showed that the pulse generator performed according to functional specifications. With the exception of the stripped setscrew, there were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6) 2012, a vns implanting assistant surgeon reported during a new vns patient's implant surgery that when he tried to insert the lead into the header and tighten up the setscrew, the torque screw did not click confirming it was fully tightened. The screw just continued to turn. The lead was secured in the port, so the surgeon attempted to loosen the screw to see if he could remove the lead pin and re-insert it. The screw continued to rotate in a counter-clockwise rotation, but he was unable to remove the lead pin. The senior surgeon then attempted to remove the lead pin and was successful in doing so. They inspected the header of the generator and the screw seemed in place in the block and the port was clear. The senior surgeon re-inserted the lead, but the setscrew continued to turn again without clicking. There was no resistance this time to the rotation of the screwdriver and the lead could not be secured. Another accessory pack was opened and another screwdriver was tried with no success. Therefore another generator was opened and used along with the screwdriver that came with the new generator. The lead was inserted and screwed down normally with 3-4 clicks being audible. The generator and screwdrivers that the surgeon was having difficulty securing the setscrew with were returned to the manufacturer on (b)(4) 2012, for product analysis that is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667123
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dennis100
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« Reply #31 on: March 13, 2018, 12:24:54 AM »

Model Number 102
Event Date 07/26/2012
Event Type Malfunction
Event Description
It was reported that during surgery, the hex screwdriver that came with the generator would not click when tightening the hex screw. A different hex screw driver was then utilized. This screwdriver produced the clicking noise indicating that the hex screw was properly tightened and the generator was implanted. The hex screwdriver was returned and product analysis was performed. During product analysis, the returned hex screwdriver was able to seat fully into a setscrew socket. However, it was unable to tighten the setscrew onto a bench test resistor using a bench generator. The torque wrench housing would spin on the hex shaft. It was also observed that the shaft of the screwdriver was pushed in to the plastic housing. The mechanical anomaly of the hex screwdriver most likely contributed to the allegation of being unable to click when attempting to tighten the setscrew.

Event Description
Additional product analysis on the torque wrench was performed by the wrench manufacturer. It was noted during their analysis that the spline on the unit was "small" and that it "did not have enough grab on the plastic nose cone". Per the analysis, the small spline along with some excessive force applied to the unit by the user allowed the tip to be pushed into the nose cone far enough that it would not engage on the plastic and allowing the tip to spin freely.

Manufacturer Narrative
The generator was not returned as it was successfully implanted. The suspect wrench was returned for analysis, which showed the shaft of the hex screwdriver was pushed up into the torque wrench housing, prohibiting it from properly torqueing. While a device failure was confirmed it did not result in death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2714354
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dennis100
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« Reply #32 on: March 16, 2018, 12:24:50 AM »

Model Number 102
Event Date 08/20/2012
Event Type Malfunction
Event Description
It was reported by the distributor that during an initial implant surgery, a torque wrench did not click when tightening the screw in the implanted generator. Another torque wrench was used to tighten the screw, but no troubleshooting was reported to have occurred. No accessory pack was used to try and troubleshoot the event. The torque wrench was received by the manufacturer on (b)(6) 2012 for product analysis. Examination revealed damage to the hex tip of the shaft. The torque wrench damage was most likely due to the torque wrench tip not fully inserted into the hex head of the setscrew. However, based on the identified damaged on the hex head may confirm this to be a contributing factor to the reported event. All required dimensions were found to be within tolerance, as was the torque setting when the shaft was properly used.

Manufacturer Narrative
Although the generator was not returned for analysis, product analysis confirmed damage to the hex tip of the shaft most likely due to user error by incomplete insertion into the setscrew socket. No death or serious injury resulted as a result of this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744161
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dennis100
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« Reply #33 on: April 13, 2018, 12:59:38 AM »

Model Number 103
Device Problem Premature end-of-life indicator
Event Date 11/07/2016
Event Type  Malfunction   
Event Description
It was reported by the surgeon's office that electrocautery was not used during the repositioning surgery reported in mfr. Report # 1644487-2016-02776. They indicated that they were able to interrogate the generator after the surgery. No additional relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
Around a month after a repositioning due to migration of the patient's generator, captured in mfr. Report # 1644487-2016-02776, a company representative interrogated the patient's device and noted it was pulse-disabled even though the battery icon showed full charge. System diagnostics confirmed device function. The device was able to be programmed back on. No additional relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
Additional programming history was reviewed from the date of the repositioning surgery. The internal data of the generator revealed that the patient's generator was pulse-disabled on the date of surgery. The information also revealed that the generator's voltage dropped sharply within two hours on the date of surgery. This drop in voltage into pulse-disabled status is consistent with the behavior of generators exposed to electrostatic discharge during the repositioning surgery reported in mfr. Report #1644487-2017-03249. Possible sources of electrostatic discharge during a repositioning surgery would be use of electrocautery around the generator or electrostatic discharge through the torque wrench. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.
 
Manufacturer Narrative
Evaluation codes (refer to coding manual), corrected data: results code was inadvertently reported in the initial mdr. Results code was inadvertently excluded from the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6255218
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dennis100
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« Reply #34 on: April 14, 2018, 12:06:32 AM »

Model Number 102
Event Date 02/04/2013
Event Type  Malfunction   
Event Description
Reporter indicated that during initial vns implant surgery of a patient, the hex screwdriver did not "click" and appeared to "spin around" in the generator receptacle. An additional hex screwdriver was used with the same results. While removing the lead from the generator, the lead reportedly broke. A new vns lead and generator were used to complete the surgery, and an audible "click" was heard when using the screwdriver. The generator, lead and hex screwdrivers involved have been returned and are pending analysis. Analysis of the lead did not identify a fracture. During the visual analysis the connector boot / inner silicone tubes appeared to be torn in half approximately 3mm from the end of the 2nd o-ring (at the end of the connector ring) and the appearance of the connector boot / connector ring backfill interface area suggests there was partial detachment. With the exception of the torn connector boot, the condition of the returned lead portion is consistent with conditions that typically exist following an attempted implant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead assembly were performed with no discontinuities identified. No coil breaks were found. On the findings in the product analysis lab, there is no evidence to suggest any device-related anomaly with the returned lead. Analysis of the generator and screwdrivers is pending.
 
Manufacturer Narrative
Device failure occurred, but this was likely due to user error; this did not cause or contribute to a serious injury or death.
 
Event Description
Analysis of the hex screwdriver packaged with the generator, based on the dimensional analysis, confirmed the hex screwdriver met design requirements. There were no performance or any other type of adverse conditions found with the hex screwdriver. The decontamination process showed the pulse generator was received with the lead connected. The lead was observed to be secured with the setscrew and both (lead and setscrew) were easily removed from the pulse generator. Visual examination, performed at the pa test bench, showed tool marks on the pulse generator case and header. These tool marks are most likely associated with manipulation of the device during the explant procedure, as the observed markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). The septum was not cored. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. The returned setscrew hex socket was observed to be stripped. No burred or stripped threads were observed on the returned setscrew or the negative connector block of the returned pulse generator. However, the flat area and striations observed at the starting thread of the returned setscrew, suggests the setscrew was partially down during lead insertion. The returned setscrew was mounted into the negative connector block of a bench generator with no difficulties. Due to the stripped setscrew hex socket, no attempt was made to set the setscrew. A bench lead inserted past the negative connector block of the retuned pulse generator and was secured with a bench setscrew, no difficulties observed (lab conditions). The set screw shows that the hex socket depth is 0. 050 inches minimum. The returned hex screwdriver shows that approximately 0. 030 inches of the hex shaft end was damaged, rounded (non-hex shaped). These measurements suggest that the hex screwdriver was not fully engaged into the setscrew hex socket. Analysis of the hex screwdriver in the accessory kit identified that approximately 0. 030 inches of the hex shaft end is damaged, rounded (non-hex shaped). Per the hex screwdriver specification, the acquired measurements (area not affected by damage) met design requirements.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2988259
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dennis100
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« Reply #35 on: June 08, 2018, 02:40:05 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 05/02/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was undergoing generator replacement surgery, and the new lead was connected to the lead outside of the pocket. Diagnostics were within normal limits at that time. The surgeon then placed the generator in the pocket, and the device was communicated with again. The battery was at end of service, even though it had full battery prior to being placed in the pocket. The company representative that was present at the surgery could not see if electro-cautery equipment was in the field while the generator was being implanted or if the metal part of the hex screwdriver was touched while screwing the set screw in. Data from the surgery was reviewed, which showed that the device was functional prior to the surgery and then, within three minutes, the generator was at end of service. This is possibly indicative of the device being hit with electro-static discharge, but there is not enough evidence at this time to determine if that was the definitive cause of the malfunction. The device history record of the generator was reviewed, and the device performed to specification prior to release. The generator has been received, but analysis has not been approved to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7545080
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dennis100
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« Reply #36 on: June 09, 2018, 01:09:18 AM »

Model Number 104
Device Problem Energy output to patient tissue incorrect
Event Date 04/24/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a generator replacement surgery due to battery depletion. Diagnostics was performed on the replacement generator while still in the packaging and the diagnostics were within normal limits. However, upon connecting the replacement generator to the implanted vns lead, high impedance was observed and the vns generator battery was at vbat < eos. The high impedance was reported in mfg. Report #1644487-2018-00804. The diagnostics also indicated that a high output current status was observed, which is reported in this mfg. Report. The surgeon stated that he may have touched the metal part of the torque screwdriver. The company representative stated that electrocautery was present in the field when the new generator was being implanted. A backup generator was implanted and a full vns replacement surgery occurred. The suspect generator was received by the manufacturer and is pending product analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7524130
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dennis100
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« Reply #37 on: September 05, 2018, 08:07:09 AM »

Model Number 102
Event Date 07/28/2011
Event Type  Malfunction   
Event Description
It was reported that the physician felt that the vns generator set screw could have potentially been stripped during vns implant surgery. The physician indicated that he was concerned because he did not hear the clicking noise made when the setscrew was tightening. He could feel the clicks and indicated that the setscrew was tightened adequately to secure the lead and generator together. The generator was implanted and the physician indicated a replacement product was not necessary. The torque wrench used during surgery has been returned for analysis. No adverse events have been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2258037
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dennis100
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« Reply #38 on: January 30, 2019, 08:57:59 AM »

Model Number 103
Event Date 08/22/2014
Event Type  Malfunction   
Event Description
It was reported that during initial implant surgery, the surgeon was unable to get the setscrew to torque initially using the torque wrench. Another accessory pack was opened and a new torque wrench was used and was able to get the setscrew to click as intended. Device diagnostics after the setscrew was in place was within normal limits (1805 ohms).
 
Event Description
Additional information was received that the torque wrench used in the patient's surgery was discarded and is unable to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103264
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dennis100
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« Reply #39 on: February 02, 2019, 07:53:19 AM »

Model Number 103
Event Date 09/19/2014
Event Type  Malfunction   
Event Description
Analysis of the returned generator was completed and found that the setscrew socket was stripped. The returned torque wrench showed that the hex shaft end was damaged and rounded (non-hex shaped). The event was likely caused by incomplete insertion of the torque wrench shaft into the setscrew socket and user-related. No device malfunction was observed.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014 due to end of service, the vns patient¿s replacement device was opened but not used as the surgeon was unable to lock the setscrew. Another generator was used for the replacement. The unused generator has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4173544
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dennis100
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« Reply #40 on: April 02, 2019, 12:10:07 AM »

Model Number 303-20
Event Date 04/25/2016
Event Type  Malfunction   
Event Description
It was reported that during generator replacement the lead showed uninsulated spot just after the connection to the generator. Furthermore, the lead was bent 180 degrees at this spot. The lead was disconnected from the old generator with some difficulties. Then, it was plugged in the new generator. The lead impedance at this time was 1400 ohms. Generator was placed into the pocket, and the wound was closed. System diagnostics was performed again and it showed impedance below 600 ohms. New generator has been left in place. Follow up indicated that no explanted generator return is possible as this was discarded after the replacement surgery. It was also reported that the physician did not suspect a lead manipulation. The device manufacturing records were reviewed. The review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Further follow up with nurse indicated that the patient underwent a lead and generator replacement; during the lead replacement on (b)(6) 2016 no hex screwdriver was available in the or to disconnect the lead from the generator. That was the reason of the replacement of the generator as well. The facility will not return the explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5673038
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dennis100
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« Reply #41 on: April 05, 2019, 01:19:20 AM »

Model Number 106
Event Date 03/25/2016
Event Type  Injury   
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
A physician initially reported that a vns patient may have a seroma or infection. The site of the seroma/infection was not stated. A subsequent call was received from a hospital indicating that the same patient had their vns pulse generator and lead explanted with no replacement. The caller indicated that at the time of the explant procedure the surgeon did not have a torque when to remove the lead from the generator so he cut the lead. The generator still has a small portion of the lead connected and this along with a portion of the lead containing the helical coil electrodes was returned for product analysis. A form received with the devices indicated the reason for explant to be infected implant. The explanted devices are currently undergoing product analysis. The surgeon confirmed that the condition was confirmed to be an infection and that the seroma was part of the infection. The infection was at both the generator and lead area and cultures indicated the infection to be pseudomonas aeruginosa.
 
Event Description
The surgeon indicated that the cause of the infection was unknown. There were no performance or any other type of adverse condition found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 2. 944 volts as measured during testing shows an ifi=no condition and device memory revealed that 5. 223% of the battery had been consumed. No obvious anomalies were noted with the returned lead portions and the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. The majority of the lead assembly (body) including the electrode array section was not returned therefore an evaluation and resulting commentary cannot be made on that portion of the lead. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions revealed no discontinuities.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5709139
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dennis100
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« Reply #42 on: June 14, 2019, 05:49:51 AM »

Model Number 106
Device Problems Detachment Of Device Component; Mechanical Problem
Event Date 11/02/2017
Event Type  Malfunction   
Event Description
It was reported that during a replacement surgery, the surgeon attempted to screw in the setscrew on the new generator with two separate screwdrivers, but he could not get the screw to click. The septum plug and screw then proceeded to fall out of the generator, so they had to implant a new generator. Reportedly, the set screw was turned in the correct direction, but it would not engage from the very first turn. There was no clicking sound at all and it wouldn¿t hold the lead securely in place. The suspect product was returned but product analysis has not been completed to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the returned generator on. Analysis found that the header septum cavity and the septum met dimensional specifications. Examination of the set screw identified indentation marks at the bottom of the set screw which shows that a lead pin or test resistor was secured with the returned set screw. Furthermore, the hex head was damaged with the hex socket rounded out, which can occur when the torque wrench is not fully engaged into the hex head. This damaged hex head would prevent the tightening of the set screw on the lead pin or the test resistor and may have contributed to the detachment of the set screw. No further anomalies were identified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7062442
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