SMITH & NEPHEW, INC. REDAPT TRIAL BODY SZ 16 +; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
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Catalog Number 71354632 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a thr, the 2 gears of a redapt trial body sz 16 + separated.There was a non-significant delay and the procedure was finished using the same device.Patient was not harmed.
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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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H3, h6: the associated device was returned and evaluated.A visual inspection did not reveal any components to be detached.The device shows signs of wear and use.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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