MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC KNOTLESS SWIVELOCK
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for 2 units of ar-2324kbcc, biocomposite knotless swivelock® anchor, 4.75 x 19.1 mm, ve5, the swivelock eyelet cut through the suture.The surgeon utilized 1.3 mm suturetape to create a cable construct over the rotator cuff prior to performing the tuberoplasty.While securing the posterior portion of the construct using an ar-2324kbcc swivelock, the suturetape was cleanly severed during insertion.The cut appeared precise, though it is unclear whether it occurred within the eyelet or elsewhere during the swivelock deployment.The surgeon proceeded by replacing both the swivelock and the suturetape on the posterior side without further issues.Later in the procedure, while securing the anterior portion of the cable construct using an ar-2324kbcc swivelock, the same issue occurred¿this time during the impaction phase.Fortunately, the swivelock remained intact and reusable.This was detected during use in a rotator cuff repair procedure involving a tuberoplasty on (b)(6) 2025.The procedure was completed successfully as they used additional sutures, the surgeon adapted by tying the suturetape to the rotator cuff using fiberwire and successfully locked it down with the same swivelock, which inserted smoothly.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK
• 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: 23366967
• Report Number: 1220246-2025-04774
• Device Sequence Number: 8915708
• Product Code: MAI
• UDI-Device Identifier: 00888867351288
• UDI-Public: (01)00888867351288(11)230918(17)270831(10)15142684
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 15142684
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown