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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/04/2025, it was reported by an arthrex subsidiary employee via (b)(4) that for an ar-8911ds mini tightrope repair kit, during button reduction, the suture broke.It was reported that based on what was observed, excessive force was applied when using two forceps.This was discovered during a lisfranc fracture fixed with two tightropes procedure with no patient harm.The case was completed with another tightrope.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on photographic evidence of an ar-8911ds, batch 32375, that displays.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 a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• 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: 23887564
• Report Number: 1220246-2025-05793
• Device Sequence Number: 4771586
• Product Code: HTN
• UDI-Device Identifier: 00888867048805
• UDI-Public: (01)00888867048805(11)241201(17)291130(10)32375
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/10/2026

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: 32375
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown