ARTHREX, INC. ARTHREX CHONDRAL DART, 18MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number AR-4005B-18 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/02/2017 |
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.The device was requested for evaluation but fragment was discarded by the customer and remainder of device was left in patient.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.If the device is returned and additional information is obtained, a follow-up report will be submitted.Device history record review revealed nothing relevant to this event.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.
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Event Description
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It was reported that during a case, the surgeon was using chondral darts to fixate a chondral defect.A small piece of the 18 mm arthrex chondral dart, ar-4005b-18, lot: e3329, broke-off during insertion.The fragment was retrieved and discarded.The majority of the implant was purposely left in the patient for additional fixation, as there were enough barbs to provide said fixation.Additional darts were used as prescribed for additional fixation.This did not cause an adverse effect to the patient, and no intervention was necessary.
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