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

Model Number ACL TIGHTROPE WITH FIBERTAG, ABS

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2022

Event Type  malfunction  

Event Description

On 03/09/2022, it was reported by a sales representative via email that while suturing the fibertag tightrope ar-1588tnt to the graft, the suture broke off right at the fibertag portion of the tightrope.This was on the first pass through the graft to position the fibertag before the whip stitch making the tightrope unusable.This was discovered during an acl quad autograft procedure on (b)(6) 2022.Additional information received 3/18/2022: case was completed using another ar-1588tnt, no further issues were reported.

Manufacturer Narrative

Complaint not confirmed.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.

• 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: 18411245
• MDR Text Key: 331531326
• Report Number: 1220246-2023-09727
• 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: 14655765
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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