SMITH & NEPHEW, INC. FEMORAL IMPLANT IMPACTOR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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Model Number 71440005 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during tkr, the surgeon noticed that the green plastic part of a femoral implant impactor was chipping off.It is unknwon how was procedure finished and if there was a delay.No other complications were reported.
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Manufacturer Narrative
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Internal reference: (b)(4).
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Event Description
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It was reported that, during tka, the surgeon noticed that the green plastic part of a femoral implant impactor was chipping off.No pieces fell inside the patient.The surgery was completed without any delay, with the same reported device.No other complications were reported.
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Manufacturer Narrative
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Additional information: d4, h3, h4.
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Event Description
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It was reported that, during tka, the surgeon noticed that the green plastic part of a femoral implant impactor broke off.No pieces fell inside the patient.The surgery was completed without any delay, with the same reported device.No other complications were reported.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.Visual inspection of the device revealed that the green can arm is broken rendering the device inoperative.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.A historical review concluded that this event was previously identified and addressed; a stress relief process was established for acetal bumpers, samples were tested in order to include the stress relief operation in the manufacturing flow and to include the inspection of stress relief temperature chart to determine compliance.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.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 future complaints and investigate as necessary.We consider this investigation closed.
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