MAUDE Adverse Event Report: Arthrex, Inc. MINI TIGHTROPE IMPLANT WITH INSERTER; WASHER, BOLT, NUT

Model Number	MINI TIGHTROPE IMPLANT WITH INSERTER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-sep-2026, a distributor reported via email that an ar-8913ds mini tightrope with inserter experienced a suture break during use.The issue was identified during a hand and wrist syndesmosis procedure performed on (b)(6)2026.An alternative implant was utilized to complete the procedure.No patient harm was reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: MINI TIGHTROPE IMPLANT WITH INSERTER
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50867358
• Report Number: 1220246-2026-04862
• Device Sequence Number: 10715984
• Product Code: HTN
• UDI-Device Identifier: 00888867048874
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K133275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: MINI TIGHTROPE IMPLANT WITH INSERTER
• Device Catalogue Number: AR-8913DS
• Device Lot Number: 15640526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown