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

Model Number	TIGHTROPE ABS, 14 MM BUTTON
Medical Device Problem Codes	Break (1069); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
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 after an initial surgery on (b)(6) 2025 the tibial button broke and became loose.Which resulted in a graft failure however the abs loop was found to be intact.This was noticed during the post operative testing.Due to this failure a revision surgery with an additional suture graft and a fixation of a bicortical post was performed on (b)(6) 2025.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 the complaint allegation was confirmed.One unpackaged ar-1588tb-1 batch 15299791 was received for evaluation.The button was received with a piece of suture, presumably part of the graft.Visual evaluation of the button found that the device was broken in half.Evaluation of both pieces revealed no sharp edges; however, some scratches, small marks, and indentations were most likely caused by other instruments.The evaluation of the returned suture noted fraying at the tips with broken filaments.The condition of the suture tips indicates that the suture was broken, as the ends do not exhibit a clean, uniform cut.Functional tests were not performed due to the device damage.The most likely cause of the reported failure was a patient-specific factor, such as the patient¿s inability or unwillingness to adequately restrict activities or adhere to postoperative instructions during the prescribed healing period.Directions for use dfu-0147-eo revision 4 tightrope® devices c.Contraindications 6.Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.E.Warnings 9.Postoperatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The postoperative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device and bone.

• Brand Name: TIGHTROPE ABS, 14 MM 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: 23816543
• Report Number: 1220246-2025-05625
• Device Sequence Number: 21355336
• Product Code: MBI
• UDI-Device Identifier: 00888867019638
• UDI-Public: (01)00888867019638(11)240808(17)290731(10)15299791
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15299791
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown