SMITH & NEPHEW, INC. FEMORAL HEAD/NECK IMPACTOR; PROSTHESISHIPSEMICONSTRAINEDMETALCERAMICPOLYMERCEMENTEDORNONPOROUSUNCEMENTED
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Model Number 71360093 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during total hip replacement, a femoral head/neck impactor cracked in pieces inside the patient.All pieces were retrieved.Surgery was completed, without any delay, with the same device.Patient was not harmed as consequence of this problem.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection of the returned femoral head/neck impactor confirms the impactor tip broken into several pieces, rendering the device inoperative.Not all pieces were not returned with the device.The device shows signs of significant 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.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are probable causes of the reported event.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 total hip replacement, a femoral head/neck impactor cracked.All pieces retrieved.Surgery was completed, without any delay, with the same device.The patient was not harmed as a consequence of this problem.
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Search Alerts/Recalls
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