This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.There are warnings in the package insert that state that this type of event can occur: under instructions for use, it states, "orthopaedic instruments do not have an indefinite functional life.All instruments are subjected to stresses that impact their effectiveness.These instruments are designed for single use due to the aspects of the design that would be compromised if used more than once.Most instrument systems include inserts/trays and a containers.Many instruments are intended for use with a specific implant.It is essential that the surgeon and surgical staff are fully conversant with the appropriate surgical technique for the instrument and any associated implant, if any." examination of returned device found no evidence of product non-conformance.Review of the device confirmed the reported condition, as the bits were stripped.Stripping is a known failure mode for driver bits, especially over time and with reuse.This failure mode was most likely due to improper torque and/or instrument wear over use and no product issue is suspected.Based off above investigation, risk analysis and complaint history review, no further action is required at this time; however, a conclusive root cause of the event could not be determined.
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