MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS AC TIGHTROPE REPAIR SYSTEM; WASHER, BOLT, NUT

Model Number	KNOTLESS AC TIGHTROPE REPAIR SYSTEM
Medical Device Problem Codes	Failure to Advance (2524); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 04/15/2025, it was reported by a sales representative via sems- (b)(4) that an ar-2371bl knotless ac tightrope repair system suture ripped when tensioning the clavicle button, and they were unable to achieve the final tension.As a result, they used another anchor kit.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b3, b5, g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, the application of excessive force during suture tensioning and/or adjusting the suture against a sharp or rough edge may result in suture breakage.A slow, steady pull is recommended to ensure the anchor seats properly.The complaint allegation was not confirmed.No evidence of that failure was received.
Event or Problem Description
Additional information was received on 05/26/2025: this issue occurred during an ac joint reconstruction procedure on (b)(6) 2025; all fragments were successfully retrieved from the patient.To complete the case, another ar-2371bl was utilized.No case delay was reported, and no additional anesthesia was administered.No instruments were used to prepare the bone socket for implant insertion.The patient's bone quality was average, and no adverse effects or significant damage were observed following the surgery.

• Brand Name: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Common Device Name: WASHER, BOLT, NUT
• 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: 21942991
• Report Number: 1220246-2025-01833
• Device Sequence Number: 18232352
• Product Code: HTN
• UDI-Device Identifier: 00888867340145
• UDI-Public: (01)00888867340145(11)241028(17)290930(10)15338708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K220947
• 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): 10/06/2025

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: KNOTLESS AC TIGHTROPE REPAIR SYSTEM
• Device Catalogue Number: AR-2371BL
• Device Lot Number: 15338708
• Was Device Available for Evaluation?: No
• 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: 09/30/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown