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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 it was reported by an sales representative via email that an ar-1288rtt-fc3 fibertag tightrope suture needle broke off during the second pass through the graft.This was discovered during a quad tendon autograft acl reconstruction on (b)(6) 2022 and was resolved successfully with no patient harm.
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.

• 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: 15959003
• Report Number: 1220246-2022-05920
• Device Sequence Number: 17530360
• 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
• Report Date (Section B): 12/12/2022

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: 07/31/2026
• Device Model Number: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Device Lot Number: 15011463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/12/2022
• Date Device Manufactured: 10/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown