MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK SP, 4.75X24.5MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	AR-2324BCM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (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 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 is typically caused by not inserting the implant co-axial to the bone tunnel 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.Device reported to be discarded by user.
Event or Problem Description
It was reported that four 4.75mm x 24.5mm biocomposite swivelocks were being used in a rotator cuff repair procedure.During the procedure, the bone was prepared using an sp anchor.When inserting the first swivelock, ar-2324bcm lot 10017622 (cc100895 line 176380), it bent, and was not able to be inserted successfully.Another swivelock, ar-2324bcm lot 10038551 (cc100895 line 176385) was attempted and as the anchor was being inserted into the bone, it broke.The same event happened with two other swivelocks, from lot 10038551 (cc100895 line 176385).The tip of these three anchors still remain in the patient, lodged at the bottom of the bone tunnel.All other broken pieces were retrieved.Other ar-2324bcm, 4.75mm x 24.5mm biocomposite swivelocks, implanted in a different area of the humeral head were used to complete the procedure successfully.No patient injury reported.Bone quality reported to be average.

• Brand Name: BIO-COMP SWIVELOCK SP, 4.75X24.5MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6166158
• Report Number: 1220246-2016-00563
• Device Sequence Number: 415786
• Product Code: MAI
• UDI-Device Identifier: 00888867026865
• UDI-Public: 00888867026865
• 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
• Report Date (Section B): 12/12/2016

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: 03/01/2018
• Device Catalogue Number: AR-2324BCM
• Device Lot Number: 10038551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-2324BCM, LOT 10017622, BIO-COMP SWIVELOCK SP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR