MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,BIO-COMP S-TAK SM JNT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTR ANCH,BIO-COMP S-TAK SM JNT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported on (b)(6) 2021 by a facility representative via sems that an ar-8934bcnf suture anchor broke during use.After fixing the ankle orif, the surgeon incised medially and resected the partially-torn deltoid ligament.The tibial footprint was drilled with the 2.5 mm drill bit and guide from the ar-8934dsc kit, and the anchor was inserted as per usual.The 1st anchor broke off the inserter as it was malleted into the bone tunnel, and the 2nd broke inside the bone tunnel after it was inserted ~50%.This was discovered during an unspecified time with no case involvement.

• Brand Name: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12608755
• Report Number: 1220246-2021-03757
• Device Sequence Number: 1454787
• Product Code: MAI
• UDI-Device Identifier: 00888867050365
• UDI-Public: 00888867050365
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: SUTR ANCH,BIO-COMP S-TAK SM JNT
• Device Catalogue Number: AR-8934BCNF
• Device Lot Number: 13030557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/11/2021
• Patient Sequence Number: 1