SMITH & NEPHEW, INC. 12.5MM ENTRY REAMER; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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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 06/04/2021 |
Event Type
malfunction
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Event Description
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It was reported that a 12.5mm entry reamer was chipped and dull.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 for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device shows signs of wear and tear and the tip is broken, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.
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