SMITH & NEPHEW, INC. JOURNEY DCF AP FEM CUT BLK 5; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Model Number 74012415 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2022 |
Event Type
Injury
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Event Description
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It was reported that, during total knee arthroplasty, a piece of a journey femoral cutting block size 5 broke off inside the patient while cutting the femur.All pieces were retrieved by hand.Surgery was resumed, without any delay, with a smith & nephew back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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Internal complaint reference: case (b)(4).
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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 device confirmed the stated failure mode.The device was fractured along one of the cutting slots, rendering the device inoperable.The device shows signs of extensive 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.The clinical/medical evaluation concluded that per complaint details, the device broke off inside the patient, while cutting the femur; however, all pieces were retrieved by hand with ¿no patient harm¿ or surgical delay.Reportedly, the surgery resumed without delay with a s+n back up device.Since ¿no patient harm¿, injury or surgical delay was alleged, no further medical investigation is warranted at this time.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.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 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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