MAUDE Adverse Event Report: ARTHREX, INC. KNEE FIBERTAK BUTTON; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNEE FIBERTAK 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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/01/2025, it was reported by a sales representative via (b)(4) that an ar-1288rtt2-ibs and an ar-3780sp malfunctioned during the case.The tightrope feature of the product ar-1288rtt2-ibs ripped during tensioning of the graft into the femoral tunnel.The graft had to be pulled out and re-prepped using product: ar-1588rtt2-ib.During the same case, one of the suture limbs of product: ar-3780sp tore off, rendering the implant unusable.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported and observed damage is user error, specifically, the application of excessive force during suture tensioning.Improper techniques, such as pulling too forcefully or adjusting the suture against a sharp or rough edge, may result in suture breakage.Directions for use dfu-0147-eor5_fmt_en - tightrope® devices g.Precautions 1.Knee tightropes only: excessive force on the shortening suture strands and/or tensioning the shortening suture strands not in line with the bone socket may break the strands and impair the ability to fully seat the implant.No additional force on the shortening suture strands is required when the graft/wedge construct reaches the desired position in the femoral socket, and the graft stability is verified by pulling distally on the graft.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: KNEE FIBERTAK 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: 23865317
• Report Number: 1220246-2025-05761
• Device Sequence Number: 4438450
• Product Code: MBI
• UDI-Device Identifier: 00888867431669
• UDI-Public: (01)00888867431669(11)250123(17)291231(10)15376991
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: KNEE FIBERTAK BUTTON
• Device Catalogue Number: AR-3780SP
• Device Lot Number: 15376991
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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