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

Model Number	IMPLSYS,T-RPII,RT-IB,DRILL,FBRLINK
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/10/2025, it was reported by a sales representative via phone that an ar-1588rt2-ibs implant system broke at the knotless mechanism.This occurred during an acl reconstruction on (b)(6) 2025, when tensioning the tightrope and pulling the graft into the socket it broke at the knotless mechanism.The fragments were all retrieved from the patient.The procedure was completed using another ar-1588rt2-ibs.There was no harm on the patient.There was about a 15 minute delay and it is unknown if additional was administered.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 either excessive force used during suture passing, the device coming in contact with another device during use, and/or improper surgical technique.

• Brand Name: IMPLSYS,T-RPII,RT-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: 21679007
• Report Number: 1220246-2025-01131
• Device Sequence Number: 12697851
• Product Code: MBI
• UDI-Device Identifier: 00888867428515
• UDI-Public: (01)00888867428515(11)241216(17)290131(10)15362385
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K241235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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,T-RPII,RT-IB,DRILL,FBRLINK
• Device Catalogue Number: AR-1588RT2-IBS
• Device Lot Number: 15362385
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown