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 Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
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 04/07/2025, a sales representative reported via email that an ar-1588rt2-ibs implant system, tightrope ii rt-ib, with tightrope pin 4 mm and fiberlink suture #2, had a tightrope that would not loosen or tighten on one side.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 misuse due to use error/mishandling.

• 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: 21968709
• Report Number: 1220246-2025-01912
• Device Sequence Number: 8492578
• Product Code: MBI
• UDI-Device Identifier: 00888867428515
• UDI-Public: (01)00888867428515(11)250109(17)290131(10)15370848
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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,T-RPII,RT-IB,DRILL,FBRLINK
• Device Catalogue Number: AR-1588RT2-IBS
• Device Lot Number: 15370848
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown