SMITH & NEPHEW, INC. MIS 3.2MM X 45MM RIMMED PIN STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 74016465 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Event Description
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It was reported that, during tka surgery, one (1) mis 3.2mm x 45mm rimmed pin sterile broke off while screwing through the block.The pin was removed.The procedure was resumed, using a s+n back-up device.It is unknown if there was any delay.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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 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 specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.Based on this investigation, the need for corrective action is not indicated.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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