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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/13/2022

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 (b)(6) 2022, it was reported by a sales representative via phone that an ar-1588rtt acl tightrope needle came off.This occurred on (b)(6) 2022 during an acl when passing through the graft, once the needle was passed it completely came off.The needle was retrieved, and the case was completed using another ar-1588rtt.There was no patient effect reported.

• Brand Name: ACL TIGHTROPE WITH FIBERTAG
• Type of Device: PIN, FIXATION, SMOOTH
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15534445
• MDR Text Key: 305008570
• Report Number: 1220246-2022-05564
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/03/2022

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: 14915618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/03/2022
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1