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

Model Number FIBERTAG TIGHTROPE WITH FLIPCUTTER III

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

On 1/26/2024, it was reported by a sales representative via (b)(4) that the flipcutter iii from an ar-1288rtt-fc3 fibertag tightrope with flipcutter iii was bent and full of bone debris, not allowing for the flipcutter to close.The surgeon drilled into the joint through the femur.The flipcutter iii was adjusted to an 11 mm size.The surgeon got the flipcutter to speed before pulling into the bone.A 22 mm socket was drilled and when the flipcutter was brought back into the joint, it would not close due to the being bent and having bone debris.The flipcutter was clamped shut with a grasper.This was discovered during an aclr procedure on (b)(6) 2024.Additional information received on 2/6/2024: nothing broke inside the patient.The blade was clamped shut, and the flipcutter was removed from inside the patient without any issues.The reaming process was completed using a short flipcutter iii.All the implants from the r-1288rtt-fc3 fibertag tightrope kit were used.The case was delayed about fifteen minutes; however, additional anesthesia was not needed.The patient suffered no negative effects.

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.

• Brand Name: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Type of Device: SMOOTH FIXATION PIN
• 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: 18730501
• MDR Text Key: 335738596
• Report Number: 1220246-2024-01021
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Model Number: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 15124989
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1