ARTHREX, INC. SUTURE ANCHOR, BIO-COMP. SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
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Catalog Number AR-2324BCC |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Code Available (3191)
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Event Date 10/19/2016 |
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.This is the first of two submissions for the same patient event.The other is 1220246-2016-00486 ((b)(4)).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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.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.Device disposition unknown.
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Event Description
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It was reported to arthrex by the surgeon, via the arthrex surgical outcome system, that on (b)(6) 2016, a patient underwent a rotator cuff repair (ripstop fibertape with swivelock) using two ar-2324bcc, lot 10032194 ((b)(4)) and one ar-2324bcctt, lot 10023046 ((b)(4)).On (b)(6) 2016 the patient underwent a revision procedure because the patient was experiencing catching of the shoulder with internal rotation due to loose anchors in the sub-acromial space.The swivelock anchors were removed.No replacement anchors were used.
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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.This is a follow-up submission to reflect device evaluation.This is the first of two submissions for the same patient event.The other is 1220246-2016-00486 ((b)(6)).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.Complaint confirmed.The device met all material specifications as received.The evaluation revealed two swivelock screws with damaged distal tips.On one of the screws the proximal end is damaged.Complainant's event is typically caused by not inserting the implant co-axial to the bone tunnel, prying or leveraging during insertion, or improper bone preparation prior to insertion.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 to arthrex by the surgeon, via the arthrex surgical outcome system, that on (b)(6) 2016, a patient underwent a rotator cuff repair (ripstop fibertape with swivelock) using two ar-2324bcc, lot 10032194 ((b)(6)) and one ar-2324bcctt, lot 10023046 ((b)(6)).On (b)(6) 2016, the patient underwent a revision procedure because the patient was experiencing catching of the shoulder with internal rotation due to loose anchors in the sub-acromial space.The swivelock anchors were removed.No replacement anchors were used.
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