SMITH & NEPHEW, INC. CPCS STEM DRIVER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Catalog Number 71362631 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during a thr two (2) cpcs stem drivers broke and did not lock into definitive stem.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.No pieces fell inside the wound.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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This complaint has been reassessed based on additional information gathered by the manufacturer.It was determined that this event does not fulfill reporting requirements per 21 cfr §803.A visual/functional analysis has not revealed any deficiency with the reported device.The results of our investigation are provided as a courtesy.Results of investigation: the associated device was returned and evaluated.A visual inspection of the returned device did not reveal any pieces broken on or off the device.The device shows signs of normal wear and use.A functional evaluation reveals all components on the device are moving freely and as intended.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.This device is a reusable instrument that can be exposed to numerous surgeries.No evidence on the alleged defects were found on the device, therefore no factors that can contribute the reported event can be delineated.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 future complaints and investigate as necessary.We consider this investigation closed.
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Event Description
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It was reported that, during a thr one (1) cpcs stem driver broke and did not lock into definitive stem.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.No pieces fell inside the wound.
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Search Alerts/Recalls
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