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

Model Number	ACL TIGHTROPE WITH FIBERTAG
Medical Device Problem Codes	Positioning Failure (1158); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 04/04/2025, a distributor reported via email that an ar-1588rtt acl tightrope fibertag sutures were too loose to attach to graft clamp.This occurred during use in a case with no patient effect.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided¿which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data¿arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, specifically, improper surgical technique.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• 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: 21953829
• Report Number: 1220246-2025-01871
• Device Sequence Number: 12857642
• Product Code: MBI
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/07/2025

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 TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 15344602
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown