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Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: two advanced applicator outer shafts, two advanced applicator inner shafts and two applicator knobs were returned for investigation with the reported condition of not proper functioning.The advanced applicator outer shafts were forwarded to the manufacturing site and were checked for conformance to the specifications.Summary of the manufacturing investigation: the device received at hägendorf site ¿advanced appl outer shaft¿ article number 03.812.520 with lot number 39p2373 is in used conditions.However, no particular signs of damage are detected.When the internal shaft (03.812.521) is inserted (or the testing ping gauge ø4.55 with id (b)(4)) the sliders (60082770) are pushed outside.At this point, one of the two sliders remains stuck and it prevents the security ring from sliding.The device has been disassembled to execute dimensional tests.However, once disassembled the security ring from the device, the slider was still not properly working (remaining stuck).For this reason, the issue is not due to the ring.In order to measure the sliders, the device has been cut in correspondence of their external side closer to the handle.Functional tests were performed on ¿advanced appl outer shaft¿ article number 03.812.520 with lot number 39p2373 according to inspection sheet.The following tests were executed: functional tests carried out according to valid assembly instructions using functional gauges 60218733 with id (b)(4), 60182107 with id (b)(4) and endmass min.0.4 with id (b)(4).The device did not pass the test; caulking passage for 03.812.521 stem detail z using functional gauge pin ø4.65 and ø4.55 with id (b)(4).The device passed the test.The device did not pass all the tests performed.Since one of the two sliders (60082770) is stacking and not moving back the first functional test was not passed.The requirement not satisfied is the ability of the ring to freely move back and show the green colored ring as shown.According to pqp se_701950 version ac, the ctqs number 3 (sliding of security ring/ detach 60082775) and number 13 (security position snapping, if 03.812.521 is assembled) are not satisfied.The following documents were reviewed: device history record (dhr) 16803493; inspection sheet se_706380 version ab, ¿pa intern multiple 03.812.520¿; work instruction se_726884 version aa, ¿montage- und prüfanweisung advanced applicator¿; drawing (b)(4), version b, ¿applicator handle cpl¿; drawing (b)(4), version c, ¿schieber¿; drawing (b)(4), version a, ¿security ring¿; drawing (b)(4), version d, ¿threaded body¿.In order to perform the investigation, all the documents mentioned above, valid when the device was manufactured, have been analyzed.The manufacturing process was executed according to the analyzed documents and no anomalies were identified.A dimensional inspection has been performed on the involved components.The most relevant features (internal diameters) for security ring (60082775) have been measured according to drawing.The part resulted to be in specifications.Furthermore, even after the security ring was disassembled, the slider is blocking.For this reason, the security ring is not affecting the functionality of the device.The outer diameter of the threaded body, component 60082771, has been measured according to drawing.It resulted to be in specifications.After the device has been cut it has been possible to measure the features (which were not damaged by the cut) of the two sliders (components 60082770).In order to distinguish them a blue dot has been drawn on a side.All the features measured for both the sides resulted in specifications according to drawing.No dimensional issue has been detected.Since the functionality of the device is not satisfied, the complaint has been confirmed as manufacturing related.A non-conformance nr-0153092 (nc# (b)(4)) has been initiated in order to further investigate on the issue.Device history lot: part: 03.812.520; lot: 39p2373; manufacturing site: hägendorf; release to warehouse date: march 9, 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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