ARTHREX, INC. H/W INTERNALBRACE LGMNT AUGMNT REPR KIT; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
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Model Number H/W INTERNALBRACE LGMNT AUGMNT REPR KIT |
Device Problem
Device Slipped (1584)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2021, it was reported by a sales representative via phone that an ar-8978-cp internal brace ligament augmentation repair implant system anchor pulled out.This was discovered during a cnc internal brace on (b)(6) 2021.Once the surgeon inserted the first anchor into the patient, the screw became stuck to the inserter.The surgeon then used a hammer to tap the inserter to remove it but instead the screw pulled out.The bone hole was then too large to use another ar-8978-cp, so the surgeon then created a new bone hole, distal to the previous hole and used a ar-8919ds to complete the case.
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