MAUDE Adverse Event Report: ARTHREX, INC. LOW-PROFILE AC REPAIR SYSTEM; WASHER, BOLT, NUT

Model Number	LOW-PROFILE AC REPAIR SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 13-feb-2026, an arthrex subsidiary employee reported via email that an ar-2371 low profile ac tightrope implant system broke during placement inside the patient.All broken components were retrieved.The procedure was completed without incident using an additional ar-2370 implant (lot 15172469).There was no significant surgical delay, and no additional anesthesia was required.The issue occurred during an ac ligament reconstruction procedure performed on (b)(6) 2026.No patient harm was reported.Additional information was received on 19-feb-2026: at this time, it is unknown which portion or component of the ar-2371 low-profile ac repair system broke in the patient.However, it was confirmed that all material, including any broken fragments, was completely removed from the patient before a new device was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: LOW-PROFILE AC 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: 24531361
• Report Number: 1220246-2026-01279
• Device Sequence Number: 16045208
• Product Code: HTN
• UDI-Device Identifier: 00888867256637
• UDI-Public: (01)00888867256637(11)250820(17)300731(10)15485778
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: LOW-PROFILE AC REPAIR SYSTEM
• Device Catalogue Number: AR-2371
• Device Lot Number: 15485778
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown