SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 7MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number 72204397 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
Event Type
malfunction
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Event Description
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It was reported that during an anterior cruciate ligament surgery, the biosure regenesorb interference screw broke at the tip upon the initial screwing, despite the surgeon doing the necessary technique during the implantation.All broken pieces were removed using forceps.The procedure was successfully completed with a delay of 5 minutes using a smith and nephew back up device.No further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference: case: (b)(4).
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Manufacturer Narrative
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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.A review of the material specifications found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.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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Search Alerts/Recalls
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