BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5 CM ANGLE ATTACHMENT

    MDR report key: 3955397 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13552
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    January 23, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS IN PROCESS. WHEN THE DEVICE HAS BEEN EVALUATED OR IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING THAT THE DEVICE HAD LOW POWER. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNK IF INJURY OR MED INTERVENTION OCCURRED. THE DATE OF THE EVENT IS UNK. THERE IS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654066 10.5 CM ANGLE ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1