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

Model Number ACL TIGHTROPE WITH FIBERTAG, ABS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

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 12th march 2024, it was reported by a sales rep via email that for 2 units of ar-1588tnt (acl fibertag tightrope abs implant) whilst they were being attached to the quads tendon, the suture attached to the needle pulled out of the knee.For the first ar-1588tnt, the suture was pulled out of needle at the commencement of fibertag being attached.A new fibertag was opened which was the second ar-1588tnt.For the second ar-1588tnt, the suture pulled out of the needle midway through attaching the fibertag.This was detected during use in an acl reconstruction with quads graft procedure on (b)(6) 2024.The procedure was completed successfully as a mayo needle was used to complete fixation.There was no patient harm.

• 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: jared engle ; 8009337001
• MDR Report Key: 18991131
• MDR Text Key: 338791869
• Report Number: 1220246-2024-01694
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308466
• UDI-Public: 00888867308466
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K110123
• 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: 03/28/2024

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
• Device Operator: Health Professional
• Device Model Number: ACL TIGHTROPE WITH FIBERTAG, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 15141056
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2023
• 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