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	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant has torn within the first six weeks.No further information received.Update dw 14-jan-2025: further information was provided that the initial surgery was performed on (b)(6) 2024 and the revision took place on (b)(6) 2024.The torn implant was removed and replaced with an new one implant and the gracilis.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b3, g3, h3, h6.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 a patient-specific event.

• 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: 21321355
• Report Number: 1220246-2025-00244
• Device Sequence Number: 8129117
• Product Code: HTN
• UDI-Device Identifier: 00888867340138
• UDI-Public: (01)00888867340138(11)230627(17)280531(10)15109380
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: KL AC TIGHTROPE REPAIR IMP. W/DOG BONE
• Device Catalogue Number: AR-2370BL
• Device Lot Number: 15109380
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown