It was reported that a lag screw driver broke during surgery.The associated device was not returned for evaluation.Thus the product analysis could not be performed.As batch details were not made available, the device history record review cannot be completed at this time.The lag screw driver is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Several potential factors that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to/after each use and cleaning.It was reported that a smith and nephew backup was used and there was no delay to procedure and no injury to patient.A relationship, if any, between the device and the reported incident could not be corroborated at this time.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.
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