The device, used in treatment, was returned for evaluation.A visual inspection of the returned drill guide handle did not find any obvious issues.The device shows normal signs of wear/usage.The device was manufactured in 2014.A functional evaluation was conducted with a mating device and the stated failure was confirmed.The drill guide handle will not hold a mating device as intended.A medical investigation was conducted and this complaint from the united states reports trouble with 3 intertan drill guide handles.No medical documentation was provided.Per the complaint, a change in surgical technique was required.No report was given regarding the patient harm or impact.Smith and nephew has not received adequate materials (operative reports) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.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 a manufacturing abnormality 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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