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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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 04/23/2025, it was reported by a sales representative via (b)(4) that an ar-1288rtt2-fc3 fibertag tightrope ii with internalbrace encountered an issue when tensioning the femoral tightrope, the white tensioning sutures pulled through the button.The graft was removed from the joint, and the faulty tightrope construct was discarded.The graft was then re-prepped with a new tightrope ii, and the replacement functioned as expected.The case was delayed 60 minutes, with the patient remaining under anesthesia for an undetermined additional duration.This was discovered during a quad tendon autograft acl reconstruction procedure on (b)(6) 2025.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b5, g3.
Event or Problem Description
Additional information was received on 05/09/2025: an additional 60 minutes of anesthesia were administered to the patient during the procedure.No negative effects or significant damage were observed during or after the surgery.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is approved based on photographic and video evidence submitted for evaluation.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a 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,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: 22002933
• Report Number: 1220246-2025-01994
• Device Sequence Number: 15237804
• Product Code: MBI
• UDI-Device Identifier: 00888867430341
• UDI-Public: (01)00888867430341(11)241218(17)280831(10)15363736
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 10/10/2025

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: 15363736
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 10/02/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/02/2025; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2024
• 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