It was reported that the reference ball joint screwdriver shaft tip is broken, additionally (6) impactors have wear and tear r3 liner impactor heads ii size 28mm, size 32 and size 36mm, and r3 liner impactor heads ii size 38-42mm, size 44-48mm and size 50-54mm.As this was noticed upon field inspection, there was no patient involvement.
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.A visual inspection of the returned device confirmed the stated failure modes.The tip of the device is broken, and the impactor heads are worn.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, 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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are 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.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.
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