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 08/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that a ruler has broken threads, a t-handle has broken tabs, a 12.5mm entry reamer is dull and chipped, a short hexdriver has damaged threads and a screw length sleeve is cracked at the joint.As this was noticed upon field inspection, there was not patient involvement.
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Manufacturer Narrative
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The device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned 12.5mm entry reamer confirmed the device is dull and chipped at the end.This device also has excessive wear usage.A review of complaint history did not reveal additional complaints for the listed batch.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.This device is a reusable instrument that can be exposed to numerous surgeries.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.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 for future complaints and investigate as necessary.We consider this investigation closed.
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