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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
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
It was reported that during an ask knee surgery the tightrope ripped off while tightening.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was noted that only the white suture was returned frayed and broken.Functional testing was not performed due to the damage to the device.Per the surgical technique, the sutures should be tensioned perpendicular to the button face.The sutures will break when pulled against the edge of the hole in the button (not perpendicular).Eco-37907 was implemented to improve the design of the button to reduce these failures due to misuse.The most likely cause for the reported failure can be attributed to user error of the device due to improper tensioning of the sutures.

• 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: 22134621
• Report Number: 1220246-2025-02356
• Device Sequence Number: 18288175
• Product Code: MBI
• UDI-Device Identifier: 00888867363656
• UDI-Public: (01)00888867363656(11)250123(17)291231(10)15377120
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241235
• 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): 08/18/2025

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: 15377120
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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