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

Model Number	MINI TIGHTROPE IMPLANT WITH INSERTER
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
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
It was reported by an arthrex subsidiary employee via email that an ar-8913ds mini tightrope button detached from the inserter and could not be reinstalled.This was discovered during the insertion of the implant during a procedure on 8/28/2024.The case was completed using another ar-8913ds mini tightrope.Additional information received on 9/5/2024: this was discovered during a lisfranc procedure.The button detached from the inserter but was still attached by the sutures.The case was not delayed, and no additional anesthesia was needed.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-8913ds mini tightrope® with inserter serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to device damage.Visual inspection revealed that the outer tube was bent.The sutures and buttons were not damaged.The button was attached to the shaft without issue.The most likely cause(s) of the observed and reported failure is user error and excessive forces, which can damage the device and render it inoperative.

• Brand Name: MINI TIGHTROPE IMPLANT WITH INSERTER
• 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: 20212852
• Report Number: 1220246-2024-07623
• Device Sequence Number: 17942651
• Product Code: HTN
• UDI-Device Identifier: 00888867048874
• UDI-Public: 00888867048874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2025

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: 15175575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2023
• 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