BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC CRANIOTOME, BM

    MDR report key: 3598036 · Received January 29, 2014

    Report

    Report Number
    1045834-2014-11268
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Report Date
    January 13, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    PK974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A VISUAL AND FUNCTIONAL ASSESSMENT WAS PERFORMED AND FOUND THE TIP WAS BENT AND WAS UNABLE TO INSERT A CUTTER. THEREFORE, THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE IMPROPER HANDLING.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING AN UNSPECIFIED NEURO SURGERY, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE "WAS NOT WORKING" WHEN IN USE WITH THE MOTOR DEVICE. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES REPORTED. IT WAS UNKNOWN TO THE REPORTER IF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION WERE REQUIRED. THE DATE OF THE EVENT WAS UNKNOWN. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62806 PEDIATRIC CRANIOTOME, BM BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME GFF DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MOTOR DEVICE