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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an naterior cruciate ligament surgery the needle of the device tore off the first time it was pierced through tissue.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Ne unpackaged ar-1588tnt acl-fibertag®-tightrope was received for investigation.Visual evaluation of the returned device noted that the needle was received detached from the suture.Functional testing was not performed due to the detached component.The device history record for all the associated batches for the needle component, c13484-02, used in this device were reviewed and all were found to have passed the needle pull test.This is a known manufacturing issue addressed by capa-00484.Refer to record cross reference.
Additional Manufacturer Narrative
Corrected information: d9, device received on 2/6/2025.Additional information: g3, h3, h6.Complaint allegation is confirmed.One unpackaged ar-1588tnt acl-fibertag®-tightrope was received for investigation.Visual evaluation of the returned device noted that the needle was received detached from the suture.Functional testing was not performed due to the detached component.The device history record for all the associated batches for the needle component, c13484-02, used in this device were reviewed and all were found to have passed the needle pull test.This is a known manufacturing issue addressed through capa.Refer to record cross reference.Refer to investigation photos.

• 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: 21303850
• Report Number: 1220246-2025-00150
• Device Sequence Number: 20838106
• Product Code: MBI
• UDI-Device Identifier: 00888867308466
• UDI-Public: (01)00888867308466(11)240916(17)290831(10)15317459
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15317459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/11/2025; 06/30/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/31/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• 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