MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in progress.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an anterior cruciate ligament surgery the sutures of the device tore during implant insertion.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
Since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.The most likely cause for the intra-operative suture failure is user applied mechanical forces during use.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• 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: 22997442
• Report Number: 1220246-2025-03746
• Device Sequence Number: 9469472
• Product Code: MBI
• UDI-Device Identifier: 00888867157736
• UDI-Public: (01)00888867157736(11)250117(17)291231(10)15374659
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/27/2026

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: TIGHTROPE ABS BUTTON ROUND 14MM CONCAVE
• Device Catalogue Number: AR-1588TB-4
• Device Lot Number: 15374659
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown