BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STD CRANIOTOME, THIN FOOT, BM

    MDR report key: 3984186 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16384
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    March 4, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GFF
    PMA / PMN Number
    K974025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS CURRENTLY IN PROCESS. WHEN THE EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE NEEDED SERVICE. UPON RECEIPT, THE DEVICE WAS FOUND TO HAVE A DAMAGED NEURO-TIP. IT IS UNKNOWN IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663845 STD CRANIOTOME, THIN FOOT, BM GFF DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1