BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFX OCD UNIVERSAL DRILL

    MDR report key: 3873099 · Received June 13, 2014

    Report

    Report Number
    0002936485-2014-00411
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. INFORMATION PROVIDED FROM THE SALES REPRESENTATIVE STATED THAT THE DEVICE WAS USED CORRECTLY HOWEVER IT WAS NOTED THAT THE REPRESENTATIVE WAS UNSURE REGARDING THE PATIENT BONE QUALITY. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 90 DEGREE HIP GUIDE TO DRILL INTO THE HIP, A BIT OF THE DRILL BROKE OFF AND HAD TO BE PULLED FROM THE BONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 90 DEGREE HIP GUIDE TO DRILL INTO THE HIP, A BIT OF THE DRILL BROKE OFF AND HAD TO BE PULLED FROM THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349478 MICROFX OCD UNIVERSAL DRILL REAMER HTO STRYKER ENDOSCOPY-SAN JOSE 44001

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR