BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLACKMAX-NEURO LOW PRESSURE

    MDR report key: 3984188 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-12282
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    April 12, 2011
    Report Date
    April 22, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBB
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THAT DURING SURGERY "THE INSTRUMENT MOVES WHEN THE SLEEVE LOCK IS NOT LOCKED". IT IS UNKNOWN IF INJURY, MEDICAL INTERVENTION OR SURGICAL DELAY OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664410 BLACKMAX-NEURO LOW PRESSURE HBB DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1