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

Model Number	IMPLSYS,FT T-RPII,RTT-IB,DRILL,FBRLINK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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-jan-2026, a sales representative reported via email that the tightrope sutures on an ar-1288rtt2-ibs fibertag tightrope ii with internalbrace broke.This was discovered during a procedure on (b)(6) 2026, with no reported patient harm.Additional information was received on 19-jan-2026: during an acl reconstruction procedure, the tightrope sutures on an ar-1288rtt2-ibs fibertag tightrope ii broke while shuttling the graft.The broken tightrope was removed from the patient, and the case was completed using an ar-1588btb-2j tightrope ii btb.The procedure was delayed by approximately 10 minutes, during which additional anesthesia was administered.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.

• Brand Name: IMPLSYS,FT T-RPII,RTT-IB,DRILL,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: 24177507
• Report Number: 1220246-2026-00308
• Device Sequence Number: 21213330
• Product Code: MBI
• UDI-Device Identifier: 00888867430358
• UDI-Public: (01)00888867430358(11)250528(17)300228(10)15443162
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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,DRILL,FBRLINK
• Device Catalogue Number: AR-1288RTT2-IBS
• Device Lot Number: 15443162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown