SMITH & NEPHEW, INC. JRNY II UNI RESECT AP BLOCK LM/RL SZ 4; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74016404 |
Device Problems
Material Fragmentation (1261); Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, during total knee arthroplasty, while drilling of posterior lug hole, a femoral peg drill bound in a journey ii cutting block and shed metal shavings inside the patient.The cutting block was damaged.Surgery was resumed, without any delay, using the same device.Patient was not harmed beyond the problem reported.
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Manufacturer Narrative
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H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned jrny ii uni resect ap block lm/rl sz 4 confirms multiple scratches, gouges and burrs in the metal.The device shows signs of significant wear and use.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.A review of the risk management file revealed this failure mode was previously identified.This device shows significant signs of wear/usage.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.We consider this investigation closed.
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