BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT REAMER HANDLE

    MDR report key: 5304761 · Received December 16, 2015

    Report

    Report Number
    9614497-2015-00241
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    October 26, 2015
    Report Date
    March 11, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED TO GREATBATCH MEDICAL FOR EVALUATION SO THE COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. NO FURTHER INVESTIGATION REQUIRED. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED BY THE CUSTOMER THAT THE DEVICE WILL NOT BE RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. ONCE GREATBATCH MEDICAL PERFORMS THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH 3500A FORM WILL BE SUBMITTED. COMPLAINT INFORMATION WAS PROVIDED BY MEDACTA.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THE DRIVE SHAFT OF THE REAMER HANDLE BROKE WHILE REAMING THE ACETABULUM. NO ADVERSE EVENTS OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829324 STRAIGHT REAMER HANDLE REAMER HANDLE LXH GREATBATCH MEDICAL SA 01.26.10.0102 7271080001

    Patients

    Seq Age Sex Outcome Treatment
    1