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

Model Number ACL TIGHTROPE WITH FIBERTAG, ABS

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/23/2021

Event Type  malfunction  

Event Description

It was reported that the first assist was prepping a quad link, the swaged needle came off the ar-1588tnt during the first pass.The case was completed by using a new ar-1588tnt.Additional information provided 6/23/21: the procedure being performed was a quadlink acl.The needle came off of the suture during use.No patient harm.

Manufacturer Narrative

The complaint is confirmed based on the customer provided photo, which displays the ar-1588tnt without the needle at the proximal end of the suture.The most likely cause for the reported failure can be attributed to misuse due to user error of the device due to excessive force being applied during use.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18410863
• MDR Text Key: 331523046
• Report Number: 1220246-2023-09715
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867308466
• UDI-Public: 00888867308466
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110123
• 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, ABS
• Device Catalogue Number: AR-1588TNT
• Device Lot Number: 12976358
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2021
• 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