BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER HANDLE

    MDR report key: 4865093 · Received June 22, 2015

    Report

    Report Number
    3004976965-2015-00005
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    February 23, 2015
    Report Date
    June 11, 2015
    Manufacturer
    GREATBATCH MEDICAL, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER THAT THE COMPLAINT SAMPLE WAS NOT MANUFACTURED BY GREATBATCH. NO FURTHER INVESTIGATION REQUIRED.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER THAT THE DEVICE WILL BE RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. ONCE GREATBATCH MEDICAL RECEIVES THE DEVICE, AN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE, THE REAMER SHAFT BROKE UPON REAMING THE ACETABULAR CAVITY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403273 ACETABULAR REAMER HANDLE LXH GREATBATCH MEDICAL, INC. 00-1206-090-10

    Patients

    Seq Age Sex Outcome Treatment
    1