SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 3; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012413 |
Device Problems
Crack (1135); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that a journey dcf ap fem cut blk 3 was found burred and cracked.As this was noticed upon field inspection, no patient was involved.
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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 device was not returned for evaluation and the reported event could not be confirmed.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 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 product 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 probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.We consider this investigation closed.¿.
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Manufacturer Narrative
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This complaint has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event, as the event happened in a not surgical enviroment; therefore, there was no patient involved.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
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