BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC CRANIOTOME

    MDR report key: 3851235 · Received June 5, 2014

    Report

    Report Number
    1045834-2014-12167
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONTACT PHONE NUMBER OR COMPLETE ADDRESS PROVIDED. THE SERIAL NUMBER WAS UNKNOWN. THEREFORE, DEVICE MANUFACTURE DATE IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE:DEVICE INFORMATION HAS BEEN UPDATED. IT WAS REPORTED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL. THE SERIAL NUMBER OF THE DEVICE WAS PROVIDED, (B)(4). THEREFORE, THE DEVICE MANUFACTURE DATE WAS AVAILABLE, (B)(6) 2011. 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 FROM (B)(6) THAT DURING A CRANIOTOMY OF THE FRONTAL AND TEMPORAL SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CRANIOTOME DEVICE BROKE AT THE ¿DURA MATER GUARD PART¿. THE REPORTER INDICATED THAT WHEN THE MAGNETIC RESONANCE IMAGING (MRI) PHOTO WAS CHECKED ON (B)(6) 2014, A HUGE ¿ARTIFACT" WAS OBSERVED, WHICH WAS THOUGHT TO BE A RESIDUE OF METAL. THE PATIENT WAS RE-OPERATED ON TO EXTRACT THE ARTIFACT AND IT WAS DETERMINED THAT THE ARTIFACT WAS THE TIP OF THE CRANIOTOME DEVICE WHICH HAD BROKEN OFF. IT WAS UNKNOWN TO THE REPORTER IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WAS MEDICAL OR SURGICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE REPORTER INDICATED THAT THE PATIENT WAS STILL HOSPITALIZED AND DOCTOR WAS FOLLOWING UP ON THE PATIENT¿S CONDITION. 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
    329966 PEDIATRIC CRANIOTOME MOTOR, DRILL, ELECTRIC - CRANIOTOME HBC DEPUY SYNTHES POWER TOOLS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R