ARTHREX INC. BIO-COMPOSITE CORKSCREW FT VENTED 5.5X14.7MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number AR-1927BCNF |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Weight Changes (2607)
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Event Date 03/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
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Event Description
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It was reported by the sales rep that during a patella tendon reconstruction procedure, after the surgeon drilled the patient's bone, as the surgeon was inserting the two ar-1927bcnf biocomposite corkscrew anchors (ft vent 5.5 x 14.7 mm) the anchors broke.About 6 threads broke-off each, flush (if not a little countersunk).The eyelet and sutures held in place and the internal brace held the repair.The anchor was seated at 16.5 mm and the patient's bone was very dense.A suture tape was used to help protect repair in case the remaining part of the anchor eventually migrated out and two internal braces were incorporated to augment the repair.Patient was a (b)(6).Follow-up investigation: the distal portion of the anchors which remained in the patient are approximately 8 mm.The proximal ends of the anchors are not being returned because they were fractured in multiple pieces (approximately 8 pieces total) and thrown into the biohazard bin.
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Search Alerts/Recalls
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