BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.5CM LARGE CRANIOTOME ATTCH

    MDR report key: 3790089 · Received May 5, 2014

    Report

    Report Number
    1045834-2014-11925
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION.  RELIABILITY ENGINEERING EVALUATED THE DEVICE.  AN ASSESSMENT WAS PERFORMED ON THE DEVICE WHICH FOUND THAT THE TIP WAS BROKEN OFF FROM IMPROPER ASSEMBLY OF THE ATTACHMENT ONTO THE DEVICE.  THEREFORE, THE REPORTED CONDITION WAS CONFIRMED.  THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE MISUSE, ABUSE, AND OR ERROR.  IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING, IT WAS DISCOVERED THAT THE TIP OF THE CRANIOTOME DEVICE WAS ¿BROKEN OFF¿. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267392 7.5CM LARGE CRANIOTOME ATTCH MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1