MAUDE Adverse Event Report: ARTHREX, INC. BC SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BC SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/22/2024, it was reported by a sales representative via (b)(4) that an ar-2326bcc suture anchors suture eyelet broke off the anchor.This occurred during an arthroscopic biceps tenodesis procedure the biceps had been stitched, cut, and the pilot hole had been made and had been loaded with two ar-7535 suture tape then inserted through the cannula.Prior to any tensioning the suture eyelet broke off the anchor.Another device was opened to complete the procedure.
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
Additional information was provided on 4/24/2024 where the sales representative stated that it's believed all of the fragments were retrieved from the patient, but were not certain the tiny fragment from the peek eyelet was removed.A 3.9 awl (ar-2326p) was used for the pilot hole.The bone quality was average.
Additional Manufacturer Narrative
The complaint allegation is confirmed.Based on the image provided from the field, the eyelet appeared to be broken on the proximal end.Consequently, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are misaligned insertion, and prying/leveraging the device during insertion.The complaint allegation is confirmed.

• Brand Name: BC SWIVELOCK, 3.9X17.9MM
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19330982
• Report Number: 1220246-2024-03391
• Device Sequence Number: 6816249
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: 00888867311282
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K230435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2025

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 Model Number: BC SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326BCC
• Device Lot Number: 15188215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 01/07/2025
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown