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

Model Number	ACL TIGHTROPE WITH FIBERTAG
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
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
It was reported during the anterior cruciate ligament surgery that the needle broke off the loop.The broken pieces were retrieved from the patient.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
Additional information: d9, g3, h3, h6.One unpackaged ar-1588rtt, acl fibertag® tightrope®, batch 15444019, was returned for investigation.Visual evaluation of the device noted that the needle was detached from the suture and the suture system was cut.Functional testing was not performed due to the damage to the device.Due to the suture system being cut, the complaint allegation can't be confirmed.No problem found.The complaint allegation is not confirmed.
Additional Manufacturer Narrative
One unpackaged ar-1588rtt acl fibertag® tightrope®, batch 15444019, was returned for investigation.Visual evaluation: the needle was detached from the suture, and the suture system was cut, indicating a user action rather than a device failure.Functional testing: not performed due to the damage to the device.The most likely cause of the broken sutures can be attributed to user error resulting from the misuse/mishandling of the device.Complaint allegation: cannot be confirmed because the suture system was cut, which does not indicate a spontaneous device failure.The allegation that the needle broke off the loop cannot be confirmed as the suture system was damaged by user action.Refer to the investigation photos.

• 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: 22873295
• Report Number: 1220246-2025-03595
• Device Sequence Number: 5803104
• Product Code: MBI
• UDI-Device Identifier: 00888867308459
• UDI-Public: (01)00888867308459(11)250529(17)300430(10)15444019
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2026

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: 15444019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Distributor Facility Aware Date: 08/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/01/2025; 01/23/2026
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/10/2025; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown