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

Model Number	FIBERTAG TIGHTROPE WITH FLIPCUTTER III
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2022
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
It was reported on (b)(6) 2022 by a facility representative via sems that an ar-1288rtt-fc3 flipcutter broke.This occurred during a case and broke inside the patient.Per facility: "in an acl reconstruction case this morning, the flip cutter we were using broke rather aggressively - i was in the case and can confirm that the flip cutter was being used as indicated and in the proper way.We have no explanation for why this happened other than the fact that the product is defective.Because of the nature of the broken blade and the bent tip, we are unable to remove the stepped bullet from the flip cutter (ar-1510fs-7).".

• 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: vik bajnath ; 8009337001
• MDR Report Key: 13995305
• Report Number: 1220246-2022-04702
• Device Sequence Number: 5195570
• Product Code: HTY
• UDI-Device Identifier: 00888867357624
• UDI-Public: 00888867357624
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/04/2022

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: 06/30/2025
• Device Model Number: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 13380982
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/04/2022
• Date Device Manufactured: 05/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown