BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER SUCKER SHORT (BX/20)

    MDR report key: 3981462 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-16197
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    August 10, 2012
    Report Date
    August 20, 2012
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    KDC
    PMA / PMN Number
    K822065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT 1 OF 16. REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE HAD DEBRIS IN STERILE PACKAGE. THE DEVICE WAS NOT BEING USED DURING SURGERY. NO INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFO PROVIDED. THE DATE OF THE EVENT WAS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663096 SUPER SUCKER SHORT (BX/20) KDC DEPUY SYNTHES POWER TOOLS F133063271

    Patients

    Seq Age Sex Outcome Treatment
    1