MAUDE Adverse Event Report: ARTHREX, INC. TIBIAL FIXATION KIT, 14MM BUTTON; NON-DEGRADABLE FIXATN FASTENER

Model Number	TIBIAL FIXATION KIT, 14MM BUTTON
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 that during an arthroscopic knee surgery the suture tore near the chinese finger trap.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: g3, h3, h6.The complaint allegation¿that the sutures tore¿is confirmed.Due to device contamination, only a visual evaluation was performed.Photographic evidence provided for device ar-1588tn-3, batch number 15394985, showed that the suture system was damaged, torn, and frayed.Based on the available information¿which may include the returned device (if applicable), photographs, videos, event descriptions, and any additional field data¿arthrex determined the most probable cause of the reported issue.The most likely root cause is attributed to user error, specifically the application of excessive force during suture passing, tightening, or tensioning.

• Brand Name: TIBIAL FIXATION KIT, 14MM BUTTON
• 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: 23389874
• Report Number: 1220246-2025-04823
• Device Sequence Number: 18609787
• Product Code: MBI
• UDI-Device Identifier: 00888867284159
• UDI-Public: (01)00888867284159(11)250225(17)300131(10)15394985
• 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
• Report Date (Section B): 11/17/2025

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: TIBIAL FIXATION KIT, 14MM BUTTON
• Device Catalogue Number: AR-1588TN-3
• Device Lot Number: 15394985
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/25/2025
• 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