It was reported that a intertan 3.2mm guide pin sleeve, was not able to target correctly.This occurred during surgery, while using the instrument inside the patient.Procedure was finished with a smith and nephew back up device.There was no surgical delay.No harm or injury reported on patient.
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The device, used treatment, was returned for evaluation.A visual inspection of the returned device confirms significant signs of wear and usage.There are some scratches, burrs and gouges in the device.This device was manufactured in 2018.A functional evaluation was conducted with a in house mating device and confirms the stated failure.The pin sleeve was not able to target correctly.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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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