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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint not confirmed.The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening/tensioning.; however, due to the device not being returned, we are unable to confirm the reported event.

Event Description

On (b)(6) 2022, it was reported by a sales representative via email that an ar-1588rtt acl tightrope with fibertag suture broke off from the needle when passing it.This was discovered during a procedure on (b)(6) 2022.Additional information received on (b)(6) 2022: this was discovered during a quad tendon acl procedure and completed with another ar-1588rtt acl tightrope with fibertag.Sales representative has confirm that the needle did not break at all, instead the suture broke off from the needle.

• 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: 18413614
• MDR Text Key: 331625217
• Report Number: 1220246-2023-09747
• 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: 12/28/2023

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: 14915602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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