BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IQ DRIVER

    MDR report key: 6404249 · Received March 14, 2017

    Report

    Report Number
    0001032347-2017-00183
    Event Type
    Malfunction
    Date Received
    March 14, 2017
    Date of Event
    January 24, 2017
    Report Date
    February 14, 2017
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GEY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTITY HAS BEEN CONFIRMED IN THE EVALUATION. UPON VISUAL INSPECTION THE DRIVER HAS SOME WEAR AND TEAR FROM USE. THE DRIVER WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND REPAIR. THE VENDOR FOUND THE GO-GAGE COMES OFF THE DRIVER EASILY; THEREFORE, THE COMPLAINT IS CONFIRMED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS DETERMINED TO BE COLLET WEAR. THERE ARE NO INDICATIONS OF A MANUFACTURING DEFECT. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2017-00184-2.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE REPORT 0001032347-2017-00184.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE 0001032347-2017-00184-1.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT DURING A CRANIOTOMY, THE DRIVER DID NOT GET LOCKED SO THE SHAFT CAME OFF. IT IS UNKNOWN IF THE ISSUE IS WITH THE DRIVER OR THE SHAFT. NO PATIENT INJURY WAS REPORTED, HOWEVER IT IS UNKNOWN IF THERE WAS A DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186501 IQ DRIVER BATTERY POWERED DRIVER GEY BIOMET MICROFIXATION N/A 5E0089

    Patients

    Seq Age Sex Outcome Treatment
    1