The device, intended use in treatment, was not returned for evaluation, the reported event could not be confirmed.The clinical/medical team concluded, this case reports that the reamer and reamer collet caused metal debris during use.Per email communication, all fragments were removed, and there was no patient injury or surgical delay.Therefore, since no patient harm is alleged, no further clinical assessment is warranted.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
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