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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
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
On 09/30/2025, a sales representative reported via phone that an ar-1288rtt2-fc3 implant systems flipcutter malfunctioned.This occurred during an acl reconstruction on (b)(6) 2025 when the flipcutters dial would not open the blade.Once in position they kept the guide bullet in place and opened another flipcutter to proceed.There was no harm on the patient.There was about a 30-45 second delay which did not require additional anesthesia.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1288rtt2-fc3, fibertag® tightrope® ii, batch 15427505, was received for investigation.Visual evaluation of the device noted no issues with the exterior of the device.Functional testing was performed by rotating the sizing wheel to flip the cutting tip into the reaming position, then returning the blade to its starting position by rotating the wheel back.No issues were observed during testing.No problem found.Refer to investigation photos.The complaint allegation is not confirmed.

• 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: 23290403
• Report Number: 1220246-2025-04570
• Device Sequence Number: 11977871
• Product Code: MBI
• UDI-Device Identifier: 00888867430341
• UDI-Public: (01)00888867430341(11)250428(17)290331(10)15427505
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/15/2025

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: IMPLSYS,FT T-RPII,RTT-IB,FCIII,FBRLINK
• Device Catalogue Number: AR-1288RTT2-FC3
• Device Lot Number: 15427505
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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