SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71440005 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 07/28/2020 |
Event Type
malfunction
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Event Description
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It was reported that screw broke on the impactor.It is unknown whether the breakage happened before or during surgery; however, the procedure was completed, without any delay, by using a back-up device.The patient was not harmed.
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Event Description
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It was reported that during surgery, while attaching the femoral impactor to the actual implant on the back table, screw broke on the impactor.A backup device was available and was used to complete the procedure.
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Manufacturer Narrative
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The device, used in treatment, was returned for evaluation.A visual inspection confirmed the screw is broken on the femoral implant impactor.The device shows significant signs of wear/usage.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 have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.This is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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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