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Catalog Number 013560 |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2024 |
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 a acl surgery, a drilling was carried out in the tibia with an 8mm diameter drill bit, when bone plug was going to be placed it fractured in half, it did not manage to stay inside the tunnel and it was removed.The procedure was completed without delay using a back up device.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.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no 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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Event Description
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It was reported that during a acl surgery, a drilling was carried out in the tibia with an 8mm diameter drill bit, when bone plug was going to be placed it fractured in half when trying to insert it into the tunnel, and the fragments did not remain inside the patient.The procedure was completed without delay using a back up device.No further complications were reported.
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Manufacturer Narrative
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Internal complaint reference (b)(4).H10 b5: event description updated.
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Search Alerts/Recalls
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