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

Model Number	ACL TIGHTROPE RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 1st sep 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-1588rt, acl tightrope® rt, the suture broke off suddenly when retrieving the implant.This was detected during a cruciate ligament reconstruction surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1588rt.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d2b, d9, g3, h3, h6.One unpackaged ar-1588rt tightrope®, batch 15234474, was received for investigation.Visual inspection of the returned device noted that the white sutures were torn.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure is user error, attributed to excessive force during suture passing, tightening, or tensioning.The complaint allegation is confirmed.Refer to the attached investigation photos.

• Brand Name: ACL TIGHTROPE RT
• 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: 23094785
• Report Number: 1220246-2025-03947
• Device Sequence Number: 8581910
• Product Code: MBI
• UDI-Device Identifier: 00888867019553
• UDI-Public: (01)00888867019553(11)240415(17)290331(10)15234474
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 RT
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 15234474
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown