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Catalog Number 72204044 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that during an acl, the acufex trunav retrograde drill broke near a screw located proximally to the surgeon.The drill could no longer drill, as it did not turn.A back up drill was opened and use to make the hole to place the graft.The procedure was completed, and no delay was reported.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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H11: corrected information in h6 (health effect - impact code).
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Search Alerts/Recalls
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