BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER MILLBRASSERLER USA MEDICAL, LLC MILLING HANDPIECE

    MDR report key: 5409806 · Received January 29, 2016

    Report

    Report Number
    2025102-2016-00002
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    December 29, 2015
    Report Date
    January 29, 2016
    Manufacturer
    BRASSELER USA, MEDICAL L.L.C.
    Product Code
    HSZ
    PMA / PMN Number
    K935367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RETURNED WITH A BUR/CUTTER SEIZED IN THE COLLET. UPON REMOVAL OF THE BUR/CUTTER IT WAS IDENTIFIED THAT GALLING WAS PRESENT IN THE COLLET NOSE HOUSING AND COLLET SPINDLE. THE INFORMATION PROVIDED WITH THE COMPLAINT INDICATES THAT THE BUR WAS NOT PROPERLY LOCKED IN THE COLLET PRIOR TO OPERATING THE HANDPIECE. IF THE BUR IS NOT PROPERLY LOCKED I PLACE THIS ALLOWS THE BUR TO MIGRATE DURING USE, CAUSING ADDITIONAL GALLING BETWEEN THE BUR/CUTTER AND COLLET THEN DURING TYPICAL USE AND IS LIKELY TO RESULT IN A SEIZURE OF THE BUR/CUTTER IN THE COLLET AND OTHER FAILURES. SURGEONS USING THIS SYSTEM SHOULD BE FAMILIAR W/THE PROPER USE OF THIS HANDPIECE AS INSTRUCTED IN THE ZIMMER INC. PFJ SYSTEM SURGICAL TECHNIQUE; SECTION 6.2, TO "INSERT BUR FULLY INTO COLLET UNTIL FLUSH" AND ILLUSTRATED IN FIG. 32, SHOWING THE POSITION OF A BUR/CUTTER FLUSH W/THE COLLET AND FULLY SEATED IN THE COLLET. THE COMPLAINT DESCRIPTION ALSO INDICATES THAT THE USER EXPERIENCED DIFFICULTY ACHIEVING FULL INSERTION OF THE BUR/CUTTER AND PROPER LOCK DOWN INSIDE THE COLLET DUE TO METAL TO METAL GALLING BETWEEN THE BUR/CUTTER, THE COLLET NOSE HOUSING, AND THE COLLET SPINDLE DURING A PRIOR OPERATION. EXCESSIVE BENDING, LATERAL FORCES, EXCEEDING THE RECOMMENDED PSI SETTING , AND OTHER AGGRESSIVE USE MAY CONTRIBUTE TO THE GALLING CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE FOLLOWING: ANTERIOR CUT GUIDE WAS USED CORRECTLY. CUT WAS MADE WITHOUT INCIDENT. WE SIZED THE FEMORAL TROCHLEA. SIZE 3 WAS ADEQUATE. MILLING GUIDE WAS SECURED CORRECTLY. THE BURR WAS THEN PLACED INTO THE MILLING HAND PIECE. UPON INSERTING THE BURR INTO THE HANDPIECE, THE BURR ITSELF WOULD NOT SLIDE DOWN INTO THE HANDPIECE ALL THE WAY. WE DOUBLE CHECKED TO BE SURE THE HANDPIECE WAS IN THE OPEN POSITION AND THE HAND PIECE WAS THEN TURNED TO LOCKED POSITION. AT THIS POINT WE WENT TO MILL THE FEMUR AND ONCE IN CONTACT WITH THE BONE, THE BURR SLID OUT OF POSITION IN THE HANDPIECE. WE THEN SWITCHED TO THE OTHER HANDPIECE THAT COMES IN THE SET. OPENED A NEW BURR AS WELL. AND WE ENCOUNTERED THE SAME RESULTS. THE BURR CONTINUED TO SLIDE IN THE HANDPIECE AS THE SURGEON MILLED IN THE APPROPRIATE CHANNELS. WE WERE ABLE TO COMPLETE THE CASE AND IMPLANT A ZIMMER PFR SIZE 3. HOWEVER, DR. (B)(6), WAS NOT HAPPY WITH THE PRODUCT INSTRUMENTATION. HE FELT HIS PATIENT WAS IN DANGER DUE TO THE EQUIPMENT NOT WORKING PROPERLY AND MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58583 ZIMMER MILLBRASSERLER USA MEDICAL, LLC MILLING HANDPIECE HSZ BRASSELER USA, MEDICAL L.L.C. ZIMMER MILL 00-5927-040-00 REV E

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR