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 Codes	Detachment of Device or Device Component (2907); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
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 08/12/2025, a sales representative reported via phone that two device issues occurred during a quadriceps tendon repair procedure performed on (b)(6) 2025.First, an ar-3780sp knee fibertak button failed when the sutures could not be passed through the anchor.While attempting to pass the fiberlink suture, it broke, preventing any suture conversion within the anchor.The suture was removed, but the anchor remained intact in the bone and was left in the patient.Second, an ar-2326bcc biocomposite swivelock anchor malfunctioned when the eyelet prematurely detached from the insertion handle during implantation.The thread on the eyelet was stripped in the process.The failed eyelet was successfully removed from the patient.The case was completed using an ar-5511-cp internalbrace knee ligament augmentation repair implant system.The procedure was delayed by less than 15 minutes.It is unknown whether additional anesthesia was administered.Bone preparation was performed using an ar-3710, and the patient¿s bone quality was assessed as hard.No adverse effects were reported during or after surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to misalignment insertion, and/or prying/leveraging of the device during insertion.
Additional Manufacturer Narrative
Corrected info: d2a, d2b.

• 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: 22921907
• Report Number: 1220246-2025-03676
• Device Sequence Number: 10354090
• Product Code: MAI
• UDI-Device Identifier: 00888867311282
• UDI-Public: (01)00888867311282(11)250506(17)290430(10)15431703
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K230435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2026

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: 15431703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 02/04/2026
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 11/20/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown