BEUDAMED
    FDA Adverse Event Death Summary report: N

    HALL 50 2-TRIGGER MODULAR HANDPIECE

    MDR report key: 5113425 · Received September 30, 2015

    Report

    Report Number
    1017294-2015-00046
    Event Type
    Death
    Date Received
    September 30, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 15, 2015
    Manufacturer
    CONMED LINVATEC
    Product Code
    HAB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNDERSTOOD THE PATIENT WAS UNDERGOING A HIP ARTHROPLASTY AS A RESULT OF SECONDARY (METASTATIC) BREAST CANCER. IT IS SUGGESTED THAT THE PATIENT MAY HAVE SUFFERED "BONE CEMENT IMPLANTATION SYNDROME" SINCE THE CARDIAC ARREST OCCURRED APPROXIMATELY 12 MINUTES FOLLOWING THE USE OF A LARGE QUANTITY OF BONE CEMENT BEING USED TO CEMENT THE FEMORAL PROSTHESIS. ALTERNATIVELY, THE PATIENT MAY HAVE SUFFERED A FAT EMBOLISM. THE PRO7200B HANDPIECE WAS MANUFACTURED ON 18-MAR-2014 AND THE PRO1547 ATTACHMENT WAS MANUFACTURED ON 31-MAR-2014. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR'S) FOR THESE DEVICES SHOWED NO DISCREPANCIES DURING MANUFACTURING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED PROBLEM OF "CARDIAC ARREST". THE HANDPIECES AND ATTACHMENT WERE ALL SUBJECT TO A ROUTINE INSPECTION AND TEST BY A QUALIFIED REPAIR TECHNICIAN AT THE CONMED INTERNATIONAL AFFILIATE SERVICE FACILITY IN AUSTRALIA. EACH DEVICE WAS TESTED AND FOUND MET MANUFACTURER SPECIFICATIONS AND PASSED ALL FUNCTIONAL TEST REQUIREMENTS WITH NO PROBLEMS NOTED. A REVIEW OF THE DEVICE COMPLAINT HISTORY SHOWS THERE HAVE BEEN NO SIMILAR EVENTS. NO FURTHER ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A TRIAL, WHERE A PRO7200B HALL 50 2-TRIGGER MODULAR HANDPIECE AND A PRO1547 HALL DRILL/REAM ATTACHMENT WERE USED IN A HIP ARTHROPLASTY FOR REAMING THE FEMORAL MEDULLARY CANAL, THE PATIENT WENT INTO CARDIAC ARREST". THIS EVENT OCCURRED TWELVE (12) MINUTES AFTER A LARGE QUANTITY OF BONE CEMENT WAS USED TO CEMENT THE FEMORAL PROSTHESIS". IT WAS SUBSEQUENTLY DISCOVERED THAT THE PATIENT WAS DECEASED DESPITE THE ATTEMPT BY THE FACILITY TRAUMA/RESUSCITATION TEAM TO REVIVE THE PATIENT. NEITHER THE FEMORAL PROSTHESIS NOR THE BONE CEMENT WAS MANUFACTURED AND/OR SUPPLIED BY CONMED. THIS REPORT IS SUBMITTED DUE TO THE FACT THAT THE PATIENT SUFFERED A CARDIAC ARREST WHILE UNDERGOING A SURGICAL PROCEDURE AND DURING WHICH TIME THE HANDPIECE AND ATTACHMENT WERE IN THE OPERATING ROOM. THERE HAS BEEN NO COMPLAINT REPORT RECEIVED FROM THE USER FACILITY REGARDING THE PERFORMANCE OF THE HANDPIECE OR THE ATTACHMENT. ADDITIONALLY, THERE IS NO SUGGESTION THAT THE HANDPIECE OR ATTACHMENT PLAYED ANY PART IN THE CARDIAC ARREST RESULTING IN THE PATIENT'S SUBSEQUENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643983 HALL 50 2-TRIGGER MODULAR HANDPIECE SAW, POWERED, AND ACCESSORIES HAB CONMED LINVATEC 2014-0068

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4) LONG STEM HEMIARTHROPLASTY PROSTHESI