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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 04/29/2025, a sales representative reported via email that an ar-2326bcc biocomposite swivelock anchor broke during implantation.The surgeon used the appropriately sized drill and tap for the swivelock, with the first 3.9mm swivelock functioning as intended.However, the second swivelock anchor that was used broke.To complete the repair, an additional ar-2326bcc biocomposite swivelock anchor was used.No harm was done to the patient, and no extra time was added.All broken pieces were removed.This was discovered during a hamstring repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 cause for the reported failure can be attributed to misaligned insertion; 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: jared engle ; 8009337001
• MDR Report Key: 22062769
• Report Number: 1220246-2025-02149
• Device Sequence Number: 8328525
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: (01)00888867311282(11)231017(17)270930(10)15155175
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/22/2025

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: 15155175
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown