MAUDE Adverse Event Report: ICOTEC AG VADER PEDICLE SYSTEM TORQUE WRENCH

Model Number 42-702

Device Problem Defective Device (2588)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

The inspection of further torque wrench devices by the supplier showed a sporadic untight welding seam, which allowed liquids (e.G.Cleaning or disinfection agents) and/or steam to enter the inside of the torque wrench during processing.Thus leading to corrosion of the mechanical components, leading to malfunction of the torque limiting function over time.The reason for the partial untight seam welding is the process of welding and subsequent polishing.Icotec has decided to recall all torque wrench devices ref 42-702 as a precautionary measure.

Event Description

A torque wrench was returned from an hospital.During internal testing of the device, it was detected that the torque limiting function of the wrench was not functioning correctly.The torque wrench is used to final tighten the nut screws of the icotec pedicle systems during implantation.

• Brand Name: VADER PEDICLE SYSTEM TORQUE WRENCH
• Type of Device: VADER PEDICLE SYSTEM
• Manufacturer (Section D): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer (Section G): ICOTEC AG; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• Manufacturer Contact: joerg schneider ; industriestrasse 12; altstaetten, sg 9450 ; SZ 9450
• MDR Report Key: 18534700
• MDR Text Key: 333146798
• Report Number: 3006493760-2024-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07640164844589
• UDI-Public: 07640164844589
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K222789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-702
• Device Catalogue Number: 42-702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0700-2024
• Patient Sequence Number: 1