Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 04.019.225s, lot: l769571, manufacturing site: (b)(4), release to warehouse date: april 23, 2018, expiry date: april 01, 2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.(b)(4).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) 2020, the patient underwent a revision procedure and removal of the multi lock femoral nail.The implant removal was due to the quality of implants and non-union.Initially, patient had a zimmer biomet proximal humerus plate that was revised to synthes multiloc humeral nail due to zimmer plate failure.It was also mentioned that the patient had an infection prior to surgical implant that ultimately led to the non-union.During the procedure, the femoral implant was removed ahead proximal nail to get the proximal screw still intact.The patient was then revised to a reverse shoulder.The procedure was successfully completed.It is unknown if there was a surgical delay.Patient status is unknown.This complaint involves eight (8) devices.This report is for (1) 8.5mm ti multiloc humeral nail left/cann/225mm-sterile.This is report 1 of 2 for (b)(4).
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