MAUDE Adverse Event Report: ARTHREX, INC. AC TIGHTROPE REPAIR KIT, TITANIUM; WASHER, BOLT, NUT

Model Number	AC TIGHTROPE REPAIR KIT, TITANIUM
Medical Device Problem Codes	Break (1069); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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 7th april 2025, it was reported by an arthrex employee via email that an ar-2257, ac tightrope¿ repair kit, titanium, the suture broke when retrieving.This was detected during an open reduction and internal fixation of left clavicle fracture surgery on (b)(6) 2025.The procedure was completed successfully by using a new ar-2257.There was no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-2257, batch 31679, was returned for investigation.Visual evaluation of the device noted that the blue sutures were torn.Functional testing was not performed due to the damage to the device.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.The complaint allegation is confirmed.

• Brand Name: AC TIGHTROPE REPAIR KIT, TITANIUM
• 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: 21875187
• Report Number: 1220246-2025-01608
• Device Sequence Number: 20763079
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: (01)00888867026391(11)240601(17)290531(10)31679
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/25/2025

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: AC TIGHTROPE REPAIR KIT, TITANIUM
• Device Catalogue Number: AR-2257
• Device Lot Number: 31679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 08/24/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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