SMITH & NEPHEW, INC. RDCE FRCPS W/ PTS {} BRD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
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Catalog Number 71173377 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2019 |
Event Type
malfunction
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Event Description
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It was reported that during surgery the points on the forceps were damaged.Back-up device available and used, but it was a competitor's device.No delay or injury reported.
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Manufacturer Narrative
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The associated complaint devices were returned for evaluation.The visual inspection of the returned forceps confirm the tips are damaged.These devices were manufactured in 2018.These devices show signs of significant wear and usage.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 incident.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.
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