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Catalog Number 71175072 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Event Description
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It was reported that, during an internal fixation surgery, the tip of an evos sm 2.5mm fixed handle linear hex dr has broken off, no pieces fell inside the wound, all the broken pieces were removed with tweezers and accounted.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Event Description
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It was reported that, during an internal fixation surgery, the tip of an evos sm 2.5mm fixed handle linear hex dr has broken off.All the broken pieces were removed with tweezers and accounted.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.
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Manufacturer Narrative
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H6: (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was not returned for evaluation.However, the photograph was reviewed, and revealed that the tip of the device fractured.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 based on the historical data revealed similar events for the listed batch, 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 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.Corrected data: b5: (narrative updated), h6: (health effect - impact code).
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Search Alerts/Recalls
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