MAUDE Adverse Event Report: ARTHREX, INC. MINI TIGHTROPE REPAIR; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE REPAIR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2026
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 05th mar 2026, it was reported by an arthrex employee via email that ar-8911ds mini tightrope repair batch 34065 snapped when deploying.This was detected on the same day during procedure.

• Brand Name: MINI TIGHTROPE REPAIR
• 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: 24686660
• Report Number: 1220246-2026-01628
• Device Sequence Number: 18636153
• Product Code: HTN
• UDI-Device Identifier: 00888867048805
• UDI-Public: (01)00888867048805(11)250801(17)300731(10)34065
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K133275
• 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): 07/08/2026

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: MINI TIGHTROPE REPAIR
• Device Catalogue Number: AR-8911DS
• Device Lot Number: 34065
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown