SMITH & NEPHEW, INC. MI TRIAL FEM HEAD 32 +12; PROSTH,KNEE,FEMOROTI,SEMICONSTRAIN,CEMEN,METAL/POLY
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Model Number 71369718 |
Device Problems
Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2020 |
Event Type
malfunction
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Event Description
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It was reported that during upon inspection it was found that the plastic was broken.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The device, intended for use in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.
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Search Alerts/Recalls
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