SMITH & NEPHEW, INC. 12.5MM ENTRY REAMER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71631116 |
Device Problems
Break (1069); Dull, Blunt (2407)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that a medium hexdriver and a long hexdriver have damage threads, a 12.5mm entry reamer is chipped and dull, a lid for outer cases has a broken clasp and a ruler has broken threads.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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Internal complaint reference (b)(4).The device, intended for use in treatment was returned for evaluation: a visual inspection of the returned device confirmed the stated failure mode.The 12.5mm entry reamer is chipped and dull rendering device inoperative.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 incidents.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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Search Alerts/Recalls
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