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

Model Number	RT IB TIGHTROPE W FLIPCUTTER III DRILL
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/11/2023, it was reported by a sales representative via phone that an ar-1288rtib-fc3 implant system tightrope® ii rt had some kind of twist in the white suture that could not allow the suture to pass through the button to bring the graft into the socket.This occurred during an acl ligament reconstruction on (b)(6) 2023 where the case was completed by removing the device and placing the graft on another tightrope.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: complaint allegation was 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(s) for the reported failure can be a user error due to improper device technique.The complaint allegation was not confirmed.

• Brand Name: RT IB TIGHTROPE W FLIPCUTTER III DRILL
• Common Device Name: NON-DEGRADABLE FIXATION 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: emily shafer ; 8009337001
• MDR Report Key: 18464212
• Report Number: 1220246-2024-00182
• Device Sequence Number: 3100762
• Product Code: MBI
• UDI-Device Identifier: 00888867379978
• UDI-Public: 00888867379978
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• 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): 01/08/2025

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: 15097860
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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