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

Model Number ACL TIGHTROPE WITH FIBERTAG, ABS

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 11/28/2023

Event Type  Injury  

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 Description

On 17th december 2023, it was reported by a sales representative via email that an ar-1588rtt acl fibertag tightrope potentially unthreaded from locking sock when untangled.This was detected on (b)(6) 2023 during a revision acl with quads graft procedure.Pending further details from sales rep.

Manufacturer Narrative

Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Correction: h1 to n/a.

Event Description

8th jan 2024 - the procedure was completed successfully as the tightrope was unstitched from the quad graft and restitched with a new implant.12th jan 2024 - the following part numbers were used in the original acl procedure: ar-1588rt, ar-1588tn and ar-1588tb-4.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG, ABS
• 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: emily shafer ; 8009337001
• MDR Report Key: 18397841
• MDR Text Key: 331381397
• Report Number: 1220246-2023-09652
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308466
• UDI-Public: 00888867308466
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15101441
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other