SMITH & NEPHEW, INC. JRNY II UNI FEMORALTRIAL HOLDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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Model Number 74016424 |
Device Problems
Detachment of Device or Device Component (2907); Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2021 |
Event Type
Injury
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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 a tka surgery, the pin on side of journey ii uni femoraltrial holder holding the spring loaded clamps to the size of the impactor fell out.The hook, spring and pin were all recovered from the patient with tweezers and fingers.Surgery was resumed, without any delay, by changing the surgical technique.Patient was not injured as consequence of this problem.
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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 femoraltrial holder confirms one of the femoral trail holder arms broke off.The broken piece was returned with the device.The device exhibits 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 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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