The device, used in treatment, was returned for evaluation.A visual inspection and dimensional confirmed the screw is incorrect size 95mm.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A quality hold was placed in an attempt to quarantine and re-inspect additional product for this failure mode.This issue has been submitted to our capa process in accordance with applicable internal capa procedures.This issue has been elevated to our risk assessment process to determine if any additional actions are needed.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Probable causes 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 and after each use and cleaning.No further investigation is warranted for this complaint; however we 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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