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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  malfunction  

Event Description

On 29th november 2023, it was reported by a sales representative via email that an ar-1588rtt, acl fibertag® tightrope® implant, needle pulled off fibertag tightrope.This was detected during a quads acl reconstruction procedure on (b)(6) 2023.The procedure was completed successfully by opening a second implant.

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: ACL TIGHTROPE WITH FIBERTAG
• 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: 18394846
• MDR Text Key: 331676134
• Report Number: 1220246-2023-09624
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112990
• 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
• Report Date: 12/26/2023

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: ACL TIGHTROPE WITH FIBERTAG
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 15095211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2023
• 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