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

Model Number	FIBERTAG TIGHTROPE II ABS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by a sales representative via phone that an ar-1588tnt2 fibertag tightrope ii abs implant had an out-of-box issue.When opening the complaint device before use in an acl procedure on (b)(6) 2024, it was noticed that the back side was not organized well in separating the suture into left and right; it was not arranged in its normal way.The surgeon was made aware of it but, decided to proceed with using the device in the procedure.When passing through the tibia tunnel using blue fibertag stitch, the white stitches pulled completely out of the tibia tunnel and out of the tightrope, unraveling the entire implant.It left them with no stitches coming out of the tunnel and unable to attach a button to the tightrope, so the implant could not be fixated.Nothing broke inside the patient; the sutures came untethered and were removed from the patient.A part of the fibertag tightrope ii abs implant fixated to the graft was left inside the patient and was fixated with an ar-7501 suturetape and an additional ar-1588tb-3ib tightrope abs button.The procedure was completed successfully with no harm to the patient.A case delay of 20 minutes was reported, but it could not be confirmed if additional anesthesia was administered to the patient.Part of the complaint device was discarded, and no pictures were taken.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The failed device was not received for evaluation.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 concluded the most likely cause.The most likely cause of the reported failure is user error, including mishandling the device during preparation prior to the surgery.The complaint was not confirmed.The device was not received for evaluation, and no evidence of the failure was received.

• 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: 21083306
• Report Number: 1220246-2025-09226
• Device Sequence Number: 6831877
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: (01)00888867426696(11)240619(17)290531(10)15276005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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): 07/18/2025

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: FIBERTAG TIGHTROPE II ABS
• Device Catalogue Number: AR-1588TNT2
• Device Lot Number: 15276005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• 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