BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER SHAFT

    MDR report key: 4102508 · Received August 27, 2014

    Report

    Report Number
    9614497-2014-00207
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. FAILURE MODE IS AN IMPACT TYPE FAILURE MODE INDICATING THAT THIS PART MAY HAVE BEEN SUBJECTED TO SOME MISUSE. DHR WAS NOT REVIEWED. MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS GENERALLY DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 1

    PER EMAIL RECEIVED ON (B)(4) 2014 CUSTOMER REPORTS; DURING AN UNK PROCEDURE ON A PT (UNK AGE NAD GENDER) THE SURGEON WAS REAMING ACETABLUM WHEN THE REAMER SNAPPED AT THE JUNCTURE FOR THE QUICK CONNECT. NO PT INJURY OR ADVERSE EVENTS REPORTED. SURGERY WAS COMPLETED WITH ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518980 ACETABULAR REAMER SHAFT REAMER HANDLE EJB GREATBATCH MEDICAL SA 1206-90-10 75146400

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK