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Catalog Number 71174985 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
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 a tibia plateau procedure, the tip of a t7 linear driver shaft w/ ao qc broke off while inserting a screw.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
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Event Description
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It was reported that, during a tibia plateau procedure, the tip of a t7 linear driver shaft w/ ao qc broke off while inserting a screw.All broken pieces accounted for and removed using a surgical instrument.The procedure was resumed, without any delay, using a s+n back-up device.Patient was not injured as consequence of this problem.
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Manufacturer Narrative
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B5: describe event or problem , d4: expiration date, d10: device available for evaluation?, h4: device manufacture date and h6: health effect - impact code.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device reveals the tip is broken off.The broken piece was not returned.The device shows signs of extensive wear and use.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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