SMITH & NEPHEW, INC. JRNY II UNI MED INSERT TRIAL SZ 5-6 9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 74036039 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference(b)(4).
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Event Description
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It was reported that, during trailing a jrny ii uni med insert trial sz 5-6 9mm broke.The procedure was performed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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Section h10: the associated device was returned and evaluated.A visual inspection of the returned device reveals pieces chipped off the device, scratches and burrs.The device shows signs of significant wear and use.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any 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 potential factors that could contribute to 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.Internal complaint reference number: (b)(4).
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