BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" DRILL W/O STOP - 2/PKG

    MDR report key: 3924310 · Received July 9, 2014

    Report

    Report Number
    0002249697-2014-02586
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K123486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PIN BECAME STUCK IN A JIG INVOLVING A DRILL BIT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW: THE COMPLAINT DATABASES SHOW THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT ID. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICES WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT THE PIN BECAME STUCK IN THE JIG AND WAS VERY DIFFICULT TO REMOVE. THE CUSTOMER REPORTED THAT ONCE THE PIN WAS REMOVED FROM THE JIG FOLLOWING COMPLETION OF THE PROCEDURE, IT WOULD NOT FIT BACK INTO ANY OF THE HOLES AND THEREFORE WAS DISCARDED BY THE HOSPITAL. THE CUSTOMER REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY WITH THE REPORTED JIG AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT THE PIN BECAME STUCK IN THE JIG AND WAS VERY DIFFICULT TO REMOVE. THE CUSTOMER REPORTED THAT ONCE THE PIN WAS REMOVED FROM THE JIG FOLLOWING COMPLETION OF THE PROCEDURE, IT WOULD NOT FIT BACK INTO ANY OF THE HOLES AND THEREFORE WAS DISCARDED BY THE HOSPITAL. THE CUSTOMER REPORTED THAT SURGERY WAS COMPLETED SUCCESSFULLY WITH THE REPORTED JIG AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399558 1/8" DRILL W/O STOP - 2/PKG INSTRUMENT JWH STRYKER ORTHOPAEDICS-MAHWAH RD9C002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other