SMITH & NEPHEW, INC. FEMORAL HEAD IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71364009 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference case- (b)(4).
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Event Description
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It was reported that, during thr surgery, while utilizing one (1) femoral head impactor, it broke while impacting the head.All parts that fractured were recovered by hand.No parts left in patient.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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Section h3, h6: the associated device was returned and evaluated.The visual inspection revealed that some pieces of the femoral head impactor tip broke off.The broken pieces were returned.Also the sleeve and head impactor sub-assembly were not returned as well.The device shows signs of significant wear and use.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.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 evidence to conclude that the product failed to meet any 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 potential factors that could contribute to 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 for future complaints and investigate as necessary.We consider this investigation closed.
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