ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number AR-1927BCF |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient demographics (age at time of event, date of birth, 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.The partial device was requested for evaluation but remains in the patient and cannot be returned 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.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by over-insertion, not inserting the implant co-axial to the bone tunnel or prying/leveraging the driver while the implant is still loaded.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Part remained in patient.
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Event Description
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It was reported that an ar-1927bcf (5.5mm x 14.7mm biocomposite corkscrew ft with two #2 fiberwire) was being used in a shoulder arthroscopy with rotator cuff repair procedure.While the surgeon was tightening the anchor, the head of the anchor broke off.The head was removed from the patient but the threaded part of the anchor was left in the patient.The procedure was completed successfully.
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