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

Model Number ACL TIGHTROPE WITH FIBERTAG

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is 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 5/5/2022, it was reported by a sales representative via email that an ar-1588rtt acl fibertag tightrope needle pulled right off while passing the first suture.This was discovered during a procedure on (b)(6) 2022.Additional information received on 5/5/2022: sales representative has confirmed that the needle did not break at all but rather detached from the sutures.By opening another tightrope, surgeon was able to complete the case without further issues.

• 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: 18418499
• MDR Text Key: 331598590
• Report Number: 1220246-2023-09763
• 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: 12/29/2023

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: 14914914
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2022
• 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