MAUDE Adverse Event Report: ARTHREX, INC. ACL REPAIR TIGHTROPE, WITH INTERNALBRACE; NON-DEGRADABLE FIXATN FASTENER

Model Number	ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 3/3/2025, it was reported by a sales representative via email that an ar-1588r-ib acl repair tightrope with internalbrace was knotted up and was unable to fix.The case was completed using another tightrope.This was discovered during an acl repair procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.
Event or Problem Description
Additional information was received on 03/10/2025: this issue occurred while passing it through the fiberrings inside of the patient.Another ar-1588r-ib was used to complete the case.The case was delayed for 30 minutes, and an unknown amount of extra anesthesia was administered due to the delay.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 misuse/mishandling of the device and/or improper surgical technique.

• Brand Name: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 21641511
• Report Number: 1220246-2025-01013
• Device Sequence Number: 7625569
• Product Code: MBI
• UDI-Device Identifier: 00888867363656
• UDI-Public: (01)00888867363656(11)220610(17)270531(10)14970192
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2025

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: ACL REPAIR TIGHTROPE, WITH INTERNALBRACE
• Device Catalogue Number: AR-1588R-IB
• Device Lot Number: 14970192
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 09/02/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 03/28/2025; 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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