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Model Number 72200146 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that during an acl reconstruction surgery, when tightening the suture loop of the endobutton, the bone tunnel got damage, in the tendon traction, the bone canal cracked and could no longer fixed with tabs.The procedure was completed using a different surgical technique (compression of biosure device fixations) in the originally drilled hole, with a non-significant surgical delay.After the surgery, no damage was found to the patient and no complications were found.No further complications 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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Internal complaint reference (b)(4).The reported device was received for evaluation.A visual inspection revealed that the device was not in its original packaging.The endobutton was returned without the dtex loop or green suture string.The white suture string was returned.There was debris on the device.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 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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.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.
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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 reconstruction surgery, when tightening the suture loop of the endobutton, the bone tunnel got damage, in the tendon traction, the bone canal cracked and could no longer fixed with tabs.The procedure was completed using a different surgical technique (compression of biosure device fixations) in the originally drilled hole, with a surgical delay greater than 30min.After the surgery, no damage was found to the patient and no complications were found.No further complications were reported.
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Search Alerts/Recalls
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