MAUDE Adverse Event Report: ARTHREX, INC. IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK; NON-DEGRADABLE FIXATN FASTENER

Model Number	IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 16-mar-2026, a sales representative reported via email that the flipcutter iii drill included in the ar-1288rtt2-fc3 fibertag tightrope ii with internalbrace experienced an issue during an acl procedure.While drilling the femoral tunnel, the surgeon started drilling into bone, then retracted the flipcutter.Approximately halfway down the tunnel, the flipcutter fractured at the tip of the shaft, not at the cutting arm.All fractured components were retrieved from the patient¿s knee.A new flipcutter was opened, and the procedure was completed using the implants from the kit.No patient harm was reported.Additional information was received on 23-mar-2026: the case was completed using an ar-1204ff flipcutter iii drill and the tightropes from the initial system.The case was not delayed, as an additional flipcutter was available, and the surgeon was able to retrieve the broken pieces without difficulty.Bone quality was reported as good.No additional anesthesia was administered, and no adverse effects were reported.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
• 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: 24816723
• Report Number: 1220246-2026-02060
• Device Sequence Number: 6027741
• Product Code: MBI
• UDI-Device Identifier: 00888867430341
• UDI-Public: (01)00888867430341(11)250625(17)290331(10)15456527
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• 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): 05/21/2026

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: IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
• Device Catalogue Number: AR-1288RTT2-FC3
• Device Lot Number: 15456527
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown