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

Model Number	ACL TIGHTROPE WITH FIBERTAG, ABS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2024
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 10/23/2024, it was reported by a distributor via (b)(4) that an ar-1588tnt acl-fibertag®-tightrope suture broke off of the needle.This occurred during an acl quad case before the nurse completed the pass through the tendon.She was not using excessive force while pulling it through and the suture came off the needle.
Additional Manufacturer Narrative
Additional information: b5, g3.Corrections: h.1 set as n/a.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon receiving additional information from the field that clarified the event and evaluation of the returned devices, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.
Event or Problem Description
Additional information was provided on 10/29/2024 where it was stated that this occurred during graft preparation, which was all tendon, a flipcutter iii was used to prepare the bone, however, the needle broke off during tendon prep, long before the tendon was passed into the bone socket.There was no delay, and they are unsure if additional anesthesia was administered.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG, 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: 20631517
• Report Number: 1220246-2024-08444
• Device Sequence Number: 20868994
• Product Code: MBI
• UDI-Device Identifier: 00888867308466
• UDI-Public: (01)00888867308466(11)240627(17)290531(10)15279615
• 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): 12/20/2024

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, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15279615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2024
• 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