MAUDE Adverse Event Report: ARTHREX, INC. KL AC TIGHTROPE REPAIR IMP. W/DOG BONE; WASHER, BOLT, NUT

Model Number	KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
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 that during an acromioclavicular joint surgery a tightrope was used.The initial surgery was performed on (b)(6) 2025.After the surgery the device tore inside the patient.The revision surgery was performed on (b)(6) 2025.The revision surgery was finished successfully with a new device with the same part number.

• Brand Name: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• 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: 23095042
• Report Number: 1220246-2025-03951
• Device Sequence Number: 21015422
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: (01)00888867340138(11)250107(17)291231(10)15369502
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K220947
• 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
• Report Date (Section B): 09/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• Device Catalogue Number: AR-2370BL
• Device Lot Number: 15369502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown