Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned accord dual ended hex driver confirmed the stated failure.The hex driving tip is rounded and deformed.A hex can strip if the torque applied to the driver exceeds the material strength or if the hex is not seated within the screw when torque is applied.This device exhibits signs of significant use and wear.This device was manufactured in 2017.A medical investigation was conducted and this case reports during use outside of the patient, the screwdriver is stripped.Per complaint description, there was no patient injury, and a delay of less than 30 minutes.The procedure was completed with a competitor device.Since no patient harm is alleged, no further clinical assessment is warranted.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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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