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	Insufficient Information (4580)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/17/2025, it was reported by a sales representative via phone that the flipcutter iii from an ar-1288rtt2-fc3 fibertag tightrope ii for internalbrace technique with flipcutteriii broke.The mechanism inside the shaft that makes the blade flip, broke during retro drilling.There were no loose fragments from the flipcutter iii and the device was completely removed from the patient.This was discovered during an aclr procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-1288rtt2-fc3, fibertag® tightrope® ii, batch 15348175, was received for investigation.Visual evaluation of the device noted that the tip was broken.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error due to applying excessive mechanical forces upon insertion and/or prying/leveraging the device during use.Refer to investigation photos.The complaint allegation is 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: 21772934
• Report Number: 1220246-2025-01216
• Device Sequence Number: 15475582
• Product Code: MBI
• UDI-Device Identifier: 00888867430341
• UDI-Public: (01)00888867430341(11)241114(17)280831(10)15348175
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 08/07/2025

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: 15348175
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Patient Sex: Unknown