BEUDAMED
    FDA Adverse Event Summary report: N

    MAKO MICS HAND PIECE

    MDR report key: 10748602 · Received October 27, 2020

    Report

    Report Number
    MW5097508
    Date Received
    October 27, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH
    Product Code
    OLO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUR SITE USES THESE MAKO MICS HAND PIECE FROM STRYKER FOR SOME OF OUR ORTHOPEDIC PROCEDURES. THE HANDPIECE IS REUSABLE AND PER THE MANUFACTURER'S GUIDELINES, IS NOT TO BE DISASSEMBLED OR IT WILL VOID THE WARRANTY ON THE DEVICE. THERE ARE CREVICES IN THIS HANDPIECE, HOWEVER, THAT BIOBURDEN AND LIQUID CAN ENTER THE HANDPIECE. THESE SUBSTANCES CANNOT BE EFFECTIVELY CLEANED FROM THE DEVICE WITHOUT REMOVING SCREW AND OPENING THE DEVICE UP. WHEN AIR WAS BLOWN ON ONE OF THESE HANDPIECES IN SPD TO DRY IT OFF AFTER CLEANING, THE BLOWER WAS PLACED NEAR A CREVICE AND WHAT APPEARED TO BE BLOODY FLUID BLEW OUT OF THE DEVICE. THEY OPTED TO DISASSEMBLE IT AND FOUND WHAT APPEARED TO BE DRY BLOOD INSIDE. REMOVING THE SCREWS TO CLEAN THE DEVICE DOES HAVE A HIGH POTENTIAL FOR STRIPPING THE SCREWS/HOLES AND IT IS DIFFICULT TO GET REPLACEMENT SCREW FROM THE MANUFACTURER WITHOUT THE PURCHASE OF A NEW DEVICE. THE REPRESENTATIVE IS AWARE OF THE ISSUE. OUR SPD WENT THROUGH ALL THE DEVICES AND DID FIND THAT THIS WAS AN ISSUE WITH ALL OF THEM AND NOT JUST ONE ISOLATED PIECE OF EQUIPMENT; 14 MAKO MIC HANDPIECE THAT HAS A BIOBURDEN SERIAL NUMBER AND BATCH NUMBER AS FOLLOWS: SN# # (B)(4) - BATCH/LOT #:42010918; SN # #(B)(4) - BATCH/LOT # 42040317; SN # (B)(4) -BATCH/LOT #42070618; SN #(B)(4) -BATCH/LOT #42010417; SN #(B)(4) - BATCH/LOT #42081018; SN #(B)(4) -BATCH/LOT #42040718; SN #(B)(4)- BATCH/LOT #42020416; SN #(B)(4) - BATCH/LOT #42010716; SN #(B)(4) - BATCH/LOT #42010916; SN #(B)(4) - BATCH/LOT #42050617; SN # (B)(4) - BATCH/LOT #42050617; SN # (B)(4) -BATCH/LOT #42030718; SN # (B)(4) - BATCH/LOT #42040616; SN #(B)(4)- BATCH/LOT #4203091. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209343 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42010918
    1209344 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42040317
    1209345 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42070618
    1209346 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42010417
    1209347 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42081018
    1209348 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42040718
    1209349 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 4020416
    1209350 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42010716
    1209351 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42010916
    1209352 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42050617
    1209353 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42050617
    1209361 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42030718
    1209362 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 42040616
    1209363 MAKO MICS HAND PIECE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER ROBOTIC INSTRUMENT HAND PIECE / STRYKER GMBH 209063 4203091

    Patients

    Seq Age Sex Outcome Treatment
    1