BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFX OCD UNIVERSAL DRILL

    MDR report key: 4090670 · Received September 15, 2014

    Report

    Report Number
    0002936485-2014-00728
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS BEEN EVALUATED IN VERIFICATION TESTING TO WITHSTAND MANY CYCLES IN A HARD BONE ANALOGUE OF 50/30 PCF WITHOUT FAILURE TO GREATER THAN 20 HOLES; IT IS ALSO POSSIBLE THAT IN THIS INSTANCE THE BONE WAS EVEN HARDER THAN THIS TEST ANALOGUE AND REPRESENTS A SMALL MAJORITY OF PATIENT ANATOMY ACROSS THE SPECTRUM OF USE. BASED ON THE AVAILABLE INFORMATION FROM THE SALES REP, THE SURGEON SKIVED UNDERNEATH THE DRILL AND THE DRILL TIP BROKE. IT IS SUGGESTED THAT THE FOLLOWING STEPS ARE FOLLOWED TO ALLEVIATE DRILL BREAKAGE: -THE SURGEON SHOULD HOLD BOTH THE DRILL AND THE GUIDE. -THE SURGEON SHOULD HOLD THE GUIDE FLUSH AGAINST THE PATIENT BONE. -IF THE SURGEON SKIVES, HE/SHE SHOULD CHECK THE DRILL BEFORE CONTINUING SURGERY. -THE SURGEON SHOULD ALWAYS DRILL IN FORWARD. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE THE REPORTED FAILURE MODE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BROKEN AND THE UNIT WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP WAS BROKEN AND THE UNIT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570112 MICROFX OCD UNIVERSAL DRILL REAMER HTO STRYKER ENDOSCOPY-SAN JOSE NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1