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Catalog Number 71631066 |
Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/14/2023 |
Event Type
malfunction
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Event Description
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It was reported that, during an internal fixation surgery, it was noticed that the medium hexdriver is broken, the rod is stuck.The surgery was completed, without any delay, with a s+n back-up device.No injuries were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Manufacturer Narrative
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D4, h4: updated.
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Manufacturer Narrative
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H3, h6: the associated device was returned and evaluated.A visual inspection reveals signs of extensive wear and use.The product marking is fading.A functional evaluation reveals the hexdriver shaft portion of the device is stuck inside the hexdriver and is unable to be removed.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 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.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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Search Alerts/Recalls
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