MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE II ABS; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAG TIGHTROPE II ABS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2023
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 10/30/2023, it was reported by a sales representative via email that an ar-1588tnt2 fibertag tightrope ii needle broke off the suture.This occurred on the first pass through the quad graft.Another tightrope was opened and the case was completed.This was discovered during an acl procedure on (b)(6) 2023.The case was delayed a few minutes.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1588tnt2 fibertag® tightrope® ii abs implant was returned for investigation.Visual inspection noted that the needle was missing.Functional testing was performed by tensioning the white loop suture strands to ensure movement of the loops and the loops were found to function as required.Capa-00484 was opened for this issue.

• Brand Name: FIBERTAG TIGHTROPE II ABS
• 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: emily shafer ; 8009337001
• MDR Report Key: 18220429
• Report Number: 1220246-2023-08937
• Device Sequence Number: 14877369
• Product Code: MBI
• UDI-Device Identifier: 00888867426696
• UDI-Public: 00888867426696
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K202581
• 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): 08/02/2024

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 II ABS
• Device Catalogue Number: AR-1588TNT2
• Device Lot Number: 15101880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown