MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS, 14 MM BUTTON; SMOOTH FIXATION PIN

Model Number TIGHTROPE ABS, 14 MM BUTTON

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/02/2024

Event Type  malfunction  

Event Description

On 11th january 2024, it was reported by a distributor via email that an ar-1588tb-1, tightrope® abs, button, round, ø 14 mm, broke in half during the last step of the procedure when our scrub nurse tech assisted the surgeon in putting the abs button on the tibial side and it broke in half during the final tension by pulling the tightrope.This was detected during use in a knee acl all inside procedure on (b)(6) 2024.The procedure was completed successfully with a second button.

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.

• Brand Name: TIGHTROPE ABS, 14 MM BUTTON
• 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: 18629096
• MDR Text Key: 334407682
• Report Number: 1220246-2024-00687
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019638
• UDI-Public: 00888867019638
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K110123
• 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
• Report Date: 02/02/2024

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: TIGHTROPE ABS, 14 MM BUTTON
• Device Catalogue Number: AR-1588TB-1
• Device Lot Number: 15128855
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• 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