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	04/18/2025
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 04/24/2025, a sales representative reported via email that multiple issues occurred during a procedure on (b)(6) 2024.The ar-1204as-100 flipcutter ii failed to flip after being drilled in the tibial tunnel, requiring another of the same products to be opened.The ar-2386-09 quadpro harvester did not successfully cut the tendon for harvest, necessitating an ar-2386-10 to complete the harvest and cut the tendon.The ar-1588tnt2 fibertag tightrope ii abs implant did not cinch down during final tensioning despite being a full tunnel where length was not an issue.The ar-1588tb-5 tightrope abs button was used over the top of the tightrope, and a synthes 3.5 cortical screw and washer were used to tie the tightrope around the screw and complete tensioning.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, h3, h6.
Event or Problem Description
Additional information has been received on 5/20/2025: an autograft quad tendon acl reconstruction procedure was performed.During the procedure, a delay of approximately 10 minutes was reported due to identified issues.However, no additional anesthesia was administered beyond the expected duration, with the patient remaining under for an additional 10 minutes.No surgical instruments or implants broke, and no fragments were encountered during the process.
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 misuse/mishandeling the device.

• 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: 22052633
• Report Number: 1220246-2025-02114
• Device Sequence Number: 7893468
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: (01)00888867426696(11)250203(17)300131(10)15382724
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/08/2025

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: 15382724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: Not provided; 10/02/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/16/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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