ARTHREX, INC. SUTURE ANCHOR, BIOCOMP SUTURETAK SMALL JOINT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number AR-8934BCNF |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/07/2014 |
Event Type
Injury
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Event Description
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It was reported that when inserting distal fibular anchor, the tip of the suturetak inserter broke.This occurred when attempting to remove inserter, the distal tip broke off in the bone with the anchor.After several attempts to remove anchor and/or metal, the surgeon decided to leave metal tip in with the anchor.Procedure was completed as planned but had to leave metal inserter tip in bone.The procedure was a brostrom, right ankle.
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Manufacturer Narrative
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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 device was requested for evaluation but was not 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 improper bone prep or 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.Unknown device disposition.
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Search Alerts/Recalls
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