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	12/26/2025
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 27th december 2025, it was reported by an arthrex employee via email that for an ar-8911ds, mini tightrope® repair kit, cannulated, stainless steel, the suture broke when the surgeon applied tension.This was detected during a lisfranc procedure on (b)(6) 2025.The procedure was completed successfully as another ar-8911ds tightrope implant was used.There was no rep present during the case.

• 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: 24039807
• Report Number: 1220246-2026-00163
• Device Sequence Number: 10498492
• Product Code: HTN
• UDI-Device Identifier: 00888867048805
• UDI-Public: (01)00888867048805(11)240401(17)290331(10)30724
• 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): 05/05/2026

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: 30724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown