MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II ABS; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE II ABS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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 11/20/2025, a sales representative reported via phone that an ar-1588tnt2 fibertag tightrope ii abs implant failed during use inside the patient.The knotless mechanism of the saddle did not fully tighten.The case was completed by cutting the tightrope and converting to an ar-1593-bc secondary fixation with biocomposite swivelock anchor.The procedure was delayed by approximately 45 minutes, with no additional anesthesia administered to the patient.This issue occurred during an acl procedure on (b)(6) 2025, with no reported patient harm.
Additional Manufacturer Narrative
Additional information: 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 user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: FIBERTAG TIGHTROPE II ABS
• 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: 23767465
• Report Number: 1220246-2025-05542
• Device Sequence Number: 18782202
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: (01)00888867426696(11)250626(17)300531(10)15457179
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• Report Date (Section B): 03/13/2026

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: FIBERTAG TIGHTROPE II ABS
• Device Catalogue Number: AR-1588TNT2
• Device Lot Number: 15457179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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