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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/29/2025, a sales representative reported via email that the black gear housing of a flipcutter iii, part of the ar-1288rtib-fc3 tightrope ii rt-ib implant system, broke during back-reaming.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 09/08/2025: during an acl reconstruction procedure on 08/29/2025, the black bulbous component of a flipcutter iii, part of the ar-1288rtib-fc3 tightrope ii rt-ib implant system, split in half.This did not occur over an open incision, and no fragments were reported to have entered the patient.The broken piece was removed from the surgical field.The case was completed using a new ar-1204ff flipcutter iii drill.There was a brief case delay of approximately two minutes, and it is unclear whether additional anesthesia was administered.No adverse effects were reported on the patient.
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 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 of the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• 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: 23096800
• Report Number: 1220246-2025-03965
• Device Sequence Number: 21208391
• Product Code: MBI
• UDI-Device Identifier: 00888867379978
• UDI-Public: (01)00888867379978(11)240503(17)280531(10)15243577
• 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): 11/10/2025

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: RT IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288RTIB-FC3
• Device Lot Number: 15243577
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown