BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT-MOD-3.2 X 55MM

    MDR report key: 4943904 · Received July 27, 2015

    Report

    Report Number
    0002249697-2015-02486
    Event Type
    Malfunction
    Date Received
    July 27, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 6, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CRACK/FRACTURE INVOLVING A MAKO DRILL BIT WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DRILL BIT FRACTURED OCCURED IN OFF-AXIS OVERLOAD. -MEDICAL RECORDS RECEIVED AND EVALUATION: NO PATIENT MEDICAL RECORDS WERE AVAILABLE FOR REVIEW. -DEVICE HISTORY REVIEW: INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAS BEEN ONE OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE FRACTURE OF THE DRILL BIT OCCURED IN AN OFF-AXIS OVERLOAD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    DRILL BIT BROKE WHILE SURGEON WAS DRILLING HOLE FOR SCREW. ALTHOUGH CASE WAS DELAYED 45 SECONDS, PATIENT WAS UNAFFECTED AND OUTCOME WAS SUCCESSFUL.

    Description of Event or Problem · 1

    DRILL BIT BROKE WHILE SURGEON WAS DRILLING HOLE FOR SCREW. ALTHOUGH CASE WAS DELAYED 45 SECONDS, PATIENT WAS UNAFFECTED AND OUTCOME WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487927 DRILL BIT-MOD-3.2 X 55MM HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES OQG STRYKER ORTHOPAEDICS-MAHWAH 110019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other