International affiliate had reported ¿old instrument has failed.¿ clarification was requested and it was reported that there was no breakage or adverse patient impact reported.There was no further information for the complaint.Based upon the information provided, it appeared that the two expedium driver shafts for si screws were worn from use.However, evaluation of returned complaint samples on (b)(4) 2014 found the threads on the driver shafts were torn.The following mfg.Medwatch reports are being filed for the two expedium driver shafts for si screws: 1526439-2014-12036, 1526439-2014-12037.
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Device manufacture date: sept-09-2008, may-12-2009.Visual examination of the returned expedium driver shaft for si screws noted that the distal tip was worn.In addition, it was indicated that the shaft's¿ threads have become torn/peeled off.No other anomalies were observed during evaluation.Review of the device history record found no discrepancies.A 12-month review of the complaint trend analysis on the product code found no emerging trends.The root cause of the distal tip of the screwdriver becoming worn and the shaft¿s threads becoming torn cannot positively be determined.However, on assessment of the condition and age of the instruments, one possible root cause for this fault may most likely be attributed to wear and tear.Additionally, the noted torn threads on the shaft, most likely has been attributed to the driver not being fully seated in a screw head during insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends have been observed, this complaint file will be closed with no further action required.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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