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

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 04/04/2025, it was reported by a sales representative via email that an ar-2324kbcct knotless swivellock was inserted into the pilot hole, malleted down to bone, and turned to advance the threads.Once the orange tab was taken off, sutures were unraveled, and when the surgeon went to take the driver out, the sutures prevented the driver from coming out, causing the anchor to rip out of bone, and the suture to remain caught in the swivelock driver.We attempted to pull the suture out of the pear head on the back table, and it would not move.This occurred during use in a case with no patient effect.Additional information requested on may 2, 2025.
Additional Manufacturer Narrative
Additional information: b3, b5, h3, h6.
Event or Problem Description
Additional information was received on 05/02/2025: this occurred during a rotator cuff repair procedure on (b)(6) 2025.The procedure was completed using one 2.6 rc fibertak for the medial row and ar-2324kbcct for the lateral row, and before insertion, the tape was removed from the eyelet to allow the fibertak suture to pass through instead.There was a case delay due to the need to retrieve the eyelet and anchor arthroscopically and prepare for a new anchor.Bone quality was decent, and the fibertak insertion proceeded without issues.The silver punch, ar-1927pb, was used to create the pilot hole.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, including improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion, which resulted in the device damage.The complaint allegation could not be confirmed, as the device was not received for evaluation, and no evidence of the reported failure was provided.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• 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: 21953060
• Report Number: 1220246-2025-01867
• Device Sequence Number: 13025771
• Product Code: MAI
• UDI-Device Identifier: 00888867351127
• UDI-Public: (01)00888867351127(11)241113(17)281031(10)15347275
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• 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): 10/06/2025

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 W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 15347275
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/15/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: Not provided; 09/30/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/28/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown