MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR BIO-SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2324BSLM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Complainant's event typically caused by not inserting the implant co-axial to the bone tunnel, improper bone preparation and/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.Device requested but not yet received.
Event or Problem Description
It was reported that during a rotator cuff repair, the ar-2324bsl (bio-swivelock sp, 4.75 mm x 24.5 mm, self-punching) was used.The surgeon attempted to insert the anchor three times and on the third attempt the self punch tip and part of the swivelock anchor became implanted and could not be removed.The surgeon reported to the sales rep that what remained in the patient was secure.The surgeon was able to tie the suture from the anchor into the rotator cuff and bring the tendon down over the implanted anchor.Surgeon also placed another swivelock and incorporated it into the repair.Sales rep states it is unclear if the additional anchor was "buddied up" or placed close to the broken anchor.It was reported that the surgeon felt everything was secure.Case was completed as planned.No x-rays were taken.
Additional Manufacturer Narrative
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.This is a follow-up submission to reflect device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The device met all material specification as received.The evaluation revealed that the anchor's distal tip is broken off.Complainant's event typically caused by 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.
Event or Problem Description
It was reported that during a rotator cuff repair, the ar-2324bsl (bio-swivelock sp, 4.75 mm x 24.5 mm, self-punching) was used.The surgeon attempted to insert the anchor three times and on the third attempt the self punch tip and part of the swivelock anchor became implanted and could not be removed.The surgeon reported to the sales rep that what remained in the patient was secure.The surgeon was able to tie the suture from the anchor into the rotator cuff and bring the tendon down over the implanted anchor.Surgeon also placed another swivelock and incorporated it into the repair.Sales rep states it is unclear if the additional anchor was "buddied up" or placed close to the broken anchor.It was reported that the surgeon felt everything was secure.Case was completed as planned.No x-rays were taken.

• Brand Name: SUTURE ANCHOR BIO-SWIVELOCK
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6000519
• Report Number: 1220246-2016-00413
• Device Sequence Number: 28909
• Product Code: MAI
• UDI-Device Identifier: 00888867026896
• UDI-Public: 00888867026896
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: AR-2324BSLM
• Device Lot Number: 1184036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2016
• Supplement Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other