BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD CRANIOTOME, BLACK MAX

    MDR report key: 3170280 · Received June 14, 2013

    Report

    Report Number
    1045834-2013-02463
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 14, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. IT WAS OBSERVED THAT THE BACK POST AND PROTECTIVE FOOT WERE DRILLED INTO AND PROTECTIVE FOOT WAS BROKEN OFF AT THE DRILLED LOCATION. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. EVIDENCE SUGGESTS THIS WAS DUE TO MISUSE AT THE CUSTOMER SITE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRANIOTOMY PROCEDURE, THE TIP OF THE ATTACHMENT DEVICE "BROKE OFF AND PENETRATED THE DURA MATER AT THE TRANSVERSE SINUS OF THE PATIENT'S CRANIUM." THE PLANNED SURGICAL PROCEDURE WAS DELAYED; HOWEVER, THE LENGTH OF THE DELAY WAS UNKNOWN TO THE REPORTER. A TRANSIENT INJURY TO THE PATIENT WAS ALLEGED, WHICH NECESSITATED ADDITIONAL MEDICAL TREATMENT TO REMEDIATE THE INJURY. THE TYPE OF ADDITIONAL TREATMENT REQUIRED WAS UNKNOWN TO THE REPORTER. THE POST-OPERATIVE STATUS OF THE PATIENT IS UNKNOWN TO THE REPORTER AT THIS TIME. 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
    272193 STANDARD CRANIOTOME, BLACK MAX BUR, SURGICAL, GENERAL & PLASTIC SURGERY - ATTACHMENT GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R