BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMT TORQUE DRIVER

    MDR report key: 3961815 · Received June 25, 2014

    Report

    Report Number
    2182979-2014-00002
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    June 24, 2014
    Manufacturer
    PMT CORP.
    Product Code
    HXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TORQUE DRIVER HAS NOT BEEN RETURNED TO PMT FOR INSPECTION/INVESTIGATION PER REQUEST OF PMT TO OUR (B)(6) DISTRIBUTOR. NO OTHER PROCEDURES USED ON THE PT WERE RETURNED TO PMT FOR INSPECTION/INVESTIGATION. THE DISTRIBUTOR HAS NOT PROVIDED ANY ADDITIONAL INFO PER PMT CORPORATION'S REQUESTS THE PAST TWO WEEKS. THE PMT TORQUE DRIVER IS SUPPOSED TO BE CALIBRATED ON AN ANNUAL BASIS PER THE LABELING ON THE DEVICE THAT STATES "CALIBRATION DUE DATE (B)(4)". THIS DEVICE HAS BEEN PAST THE CALIBRATION DUE DATE FOR OVER 7 YEARS. PMT IS ATTEMPTING TO GET BACK THE TORQUE DRIVER FOR EVALUATION BUT WE ASSUME IT WAS USER ERROR BASED UPON THE FACT THAT THE SKULL PIN PENETRATED THE THICKEST PORTION OF THE SKULL AND THE SKULL PINS ARE DESIGNED TO PENETRATE THE SKULL ONLY 2MM AND THE PORTION OF THE SKULL, THE CALOTTE, IS SEVERAL FACTORS THICKER. IT IS ASSUMED THAT THE TORQUE DRIVER WAS SET AT A HIGHER TORQUE SETTING THAN IS KNOWN BY LEARNED INTERMEDIARY FOR SUCH A PROCEDURE.

    Description of Event or Problem · 1

    INFO PROVIDED FROM THE DISTRIBUTOR ((B)(6)): DURING THE APPLICATION OF A HALO-FIXATEUR, ONE PIN BROKE THROUGH THE CALOTTE. THE PT DID NOT SUSTAIN ANY FURTHER INJURIES AND IS FREE OF COMPLAINTS. THIS OCCURED AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370525 PMT TORQUE DRIVER TORQUE DRIVER HXX PMT CORP. 1201-8 030306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention