MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE WITH FLIPCUTTER III; PIN, FIXATION, SMOOTH

Model Number	FIBERTAG TIGHTROPE WITH FLIPCUTTER III
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
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 (b)(6) 2023, it was reported by a sales representative via sems-06404807 that the tip of the flipcutter iii from an ar-1288rtt-fc3 fibertag tightrope with flipcutter iii snapped off as soon as it came in contact with the femoral wall.This was discovered during a quad acl procedure on (b)(6) 2023.All the broken fragments were removed from inside the patient.Additional information received on 11/22/2023: the broken fragments were removed using a grasper, and the case was completed using an ar-1204ff flipcutter iii.The case was delayed five minutes, and the patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, it was observed that the cutter head of the flipcutter iii drill had broken off, along with a portion of the distal end of the shaft.Only the broken ar-1288rtt-fc3 was returned from the fibertag tightrope with flipcutter iii kit.Functional testing was not performed due to the broken cutter head on the device.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion prying/leveraging the device during insertion.

• Brand Name: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Common Device Name: PIN, FIXATION, SMOOTH
• 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: 18340879
• Report Number: 1220246-2023-09456
• Device Sequence Number: 6797543
• Product Code: HTY
• UDI-Device Identifier: 00888867357624
• UDI-Public: 00888867357624
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K112990
• 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): 08/27/2024

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: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 15105532
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 12/15/2023
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown