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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 11/02/2023

Event Type  malfunction  

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 7th november 2023, it was reported by a sales rep via email that an ar-1588rtt, acl fibertag® tightrope® implant swag needle was pulled off the fibertag suture from the packaging.This was detected on 2nd november 2023 during use in a quads acl procedure.The procedure was completed successfully by opening another tightrope rtt and the quads acl graft was completed.

• 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: 18247032
• MDR Text Key: 329490505
• Report Number: 1220246-2023-09049
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/01/2023

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: 15122553
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2023
• 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