Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection the product confirmed the stated failure.The head has broken off from the shaft.The broken piece is returned with the complaint.The device was manufactured in 2014 and shows signs of significant wear/usage.A medical investigation was conducted and this case reports that the device broke during the procedure.Per complaint description, the device broke while outside of the patient.The procedure was completed using a competitor device, without any surgical delay or patient injury.Since no patient harm is alleged, no further clinical assessment is warranted at this time.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 manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.
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