Part 03.501.080, lot l254389: manufacturing site: (b)(4).Release to warehouse date: january 26, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: upon visual inspection, no issues were observed with the returned device.A functional test was performed on the returned device.During the functional test, the clamp component of the pusher assembly was not functioning properly, so the lever when released will not tension/hold as intended.The lever was loose and keeps releasing back.No dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint-relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed.The complaint condition was confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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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It was reported that on (b)(6) 2021 zipfix application instrument jammed.A backup zipfix application instrument had to be retrieved to finish tightening the implants.The surgery was delayed for four (4) minutes.The procedure was successfully completed.During investigation of the returned device, it was noted the clamp component of the pusher assembly was not functioning properly, so the lever when released will not tension/hold as intended.The lever was loose and keeps releasing back.This report is for a zipfix application instrument.This is report 1 of 1 for (b)(4).
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