MAUDE Adverse Event Report: ARTHREX, INC. RT IB TIGHTROPE W FLIPCUTTER III DRILL; NON-DEGRADABLE FIXATN FASTENER

Model Number	RT IB TIGHTROPE W FLIPCUTTER III DRILL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/14/2025, it was reported by a sales representative via email that the flipcutter iii from an (b)(6) tightrope ii rt with fibertape ib, flipcutter iii, and fiberstick implant system broke and was unable to be used.This was discovered during a procedure on ar-1288rtib-fc3 2025.Additional information was received on 10/20/2025: during the procedure, the flipcutter broke while retro drilling inside the patient.Fortunately, all fragments were successfully retrieved without complication.To complete the case, an individual ar-1240ff flipcutter iii was used.The incident did not result in any surgical delay, and no additional anesthesia was required.
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.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 is attributed to user-related factors such as off-axis drilling, excessive leverage, and excessive mechanical stress to the device.

• Brand Name: RT IB TIGHTROPE W FLIPCUTTER III DRILL
• 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: 23393366
• Report Number: 1220246-2025-04846
• Device Sequence Number: 15939112
• Product Code: MBI
• UDI-Device Identifier: 00888867379978
• UDI-Public: (01)00888867379978(11)240503(17)280531(10)15243575
• 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): 03/05/2026

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: RT IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288RTIB-FC3
• Device Lot Number: 15243575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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