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	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems-06044039 that an ar-2326bcc biocomposite swivelock inserter bent and the eyelet broke off.The surgeon had placed a cinch stitch around the biceps using an ar-13990n scorpion needle and an ar-7235 fiberlink and two cinch stitches around the subscap using (2) ar-7235t tigerlink.Then, the surgeon punched for the swivelock and ran the suture through the eyelet.As it was being tensioned down, the eyelet broke off, and the tip of the inserted bent about ninety degrees.The eyelet and inserter were removed successfully from inside the patient.This was discovered during an rcr procedure with bicep tenodesis on (b)(6) 2023.The case was completed using a 4.75 swivelock and punching a new bone hole.Additional information was received on 10/2/2023: the case was delayed two minutes; it is unknown if additional anesthesia was administered.
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.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17984034
• Report Number: 1220246-2023-08294
• Device Sequence Number: 20668713
• 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
• Report Date (Section B): 10/16/2024

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: 15139062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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