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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2022

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

It was reported on 12/05/2022 by a sales representative via sems that an ar-1588rtt tightrope needle pulled off loop with first pass through tape.Case involvement, device broke during use.

Manufacturer Narrative

Additional information: h6 the complaint device was not received for evaluation.Per the surgical technique, the sutures should be tensioned perpendicular to the button face.The sutures will break when pulled against the edge of the hole in the button (not perpendicular).Eco-37907 was implemented to improve the design of the button to reduce these failures due to misuse.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to improper tensioning of the sutures.

• 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: 16051373
• MDR Text Key: 308443611
• Report Number: 1220246-2022-05968
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308459
• UDI-Public: 00888867308459
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 05/17/2024

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
• Device Catalogue Number: AR-1588RTT
• Device Lot Number: 14948262
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1