MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE WITH FLIPCUTTER III; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE WITH FLIPCUTTER III
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 05/23/2024, it was reported by a sales representative via (b)(4) that the blade of a flipcutter iii from an ar-1288rtt-fc3 fibertag tightrope implant system got stuck in a deployed position inside the patient's joint.The guide had to be removed in conjunction with the flipcutter iii, leaving a larger bone tunnel than what was originally reamed.Additional information received on 5/29/2024: this was discovered during an acl procedure on (b)(6) 2024.A guide hammered out the stuck flipcutter, and a new individual ar-1204ff flipcutter iii was used to complete the reaming process.Removing the flipcutter took an extra ten minutes; however, additional anesthesia was not needed.
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 improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• 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: 19584837
• Report Number: 1220246-2024-06331
• Device Sequence Number: 3433966
• Product Code: MBI
• UDI-Device Identifier: 00888867357624
• UDI-Public: 00888867357624
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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): 07/02/2025

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 Expiration Date: 01/31/2026
• Device Model Number: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 14827298
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown