SMITH & NEPHEW, INC. GII TIB ALIGN SPIKED FIX ROD; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 71440198 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Event Description
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It was reported that, during tka surgery, the longer fixation spike of a gii tib align spiked fix rod was noticed to be not sharp, after it was used.It looked like the tip had broken off, though is a smooth.An x-ray was performed immediately post op to check for any metal debris, and no sign of metal work was seen.The procedure was resumed, after a significant delay, with the same device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).
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Manufacturer Narrative
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Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.However, the photographs were reviewed, and revealed the tip of the long spike fractured.The device shows signs of use.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 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 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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