BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7079213 · Received December 4, 2017

    Report

    Report Number
    3005985723-2017-00605
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 28, 2017
    Report Date
    April 11, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE MICS SCREW FALLS OFF THE HANDLE. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: NOT PERFORMED AS LOT NUMBER WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS LOT NUMBER WAS NOT PROVIDED. CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC 1429704 AND CAPA 1452931.

    Description of Event or Problem · 0

    I AM BEYOND FRUSTRATED WITH THE ISSUE(S) WE CONTINUE TO HAVE WITH THE MAKO HANDPIECE HANDLE LOOSENING AND FALLING OFF ONTO THE STERILE FIELD. THE HANDLE FELL OFF AGAIN ON A CASE THIS MORNING WITH DR. REID. THE HANDLE FELL OFF ONTO THE FLOOR, BUT THE SCREW WAS FOUND ON THE STERILE FIELD. THERE IS POTENTIAL FOR THE SCREW TO FALL INTO A PTS. WOUND, AS WELL AS THE RISK OF CONTAMINATION FROM THE INSIDE OF THE HANDLE THAT WAS NOT EXPOSED TO STEAM STERILIZATION. I HAVE REQUESTED THAT THIS PROBLEM BE ADDRESSED, AND TO DATE HAVE NOT BEEN INFORMED OF A SOLUTION. MY SUGGESTION IS TO ADD A STERILE SCREW DRIVER/ WRENCH TO THE STERILE INSTRUMENT SET-UP, SO THE SCREW CAN BE TIGHTENED INTERMITTENTLY DURING USE. SO FAR STRYKER/MAKO HAVE NOT PRESENTED US WITH AN APPROPRIATE TOOL. CURRENTLY JRI CSS (STERILIZATION DEPT.) TIGHTENS THE HANDPIECE SCREW PRIOR TO PACKAGING AND STERILIZING THE HANDPIECE, BUT THIS HAS NOT PROVEN TO FIX THE ISSUE. I HAVE BEEN TOLD THAT JRI IS THE ONLY OR HAVING THIS ISSUE. I WOULD LIKE TO REACH OUT TO OTHER FACILITIES AND THEIR STERILIZATION DEPARTMENTS TO COMPARE THEIR PREPARATION PROCEDURES FOR THE MAKO HANDPIECE. POSSIBLY, WE ARE DOING SOMETHING DIFFERENT THAT CAUSES THE SCREW TO LOOSEN.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED BY MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    I AM BEYOND FRUSTRATED WITH THE ISSUE(S) WE CONTINUE TO HAVE WITH THE MAKO HANDPIECE HANDLE LOOSENING AND FALLING OFF ONTO THE STERILE FIELD. THE HANDLE FELL OFF AGAIN ON A CASE THIS MORNING WITH DR. REID. THE HANDLE FELL OFF ONTO THE FLOOR, BUT THE SCREW WAS FOUND ON THE STERILE FIELD. THERE IS POTENTIAL FOR THE SCREW TO FALL INTO A PTS. WOUND, AS WELL AS THE RISK OF CONTAMINATION FROM THE INSIDE OF THE HANDLE THAT WAS NOT EXPOSED TO STEAM STERILIZATION. I HAVE REQUESTED THAT THIS PROBLEM BE ADDRESSED, AND TO DATE HAVE NOT BEEN INFORMED OF A SOLUTION. MY SUGGESTION IS TO ADD A STERILE SCREW DRIVER/ WRENCH TO THE STERILE INSTRUMENT SET-UP, SO THE SCREW CAN BE TIGHTENED INTERMITTENTLY DURING USE. SO FAR STRYKER/MAKO HAVE NOT PRESENTED US WITH AN APPROPRIATE TOOL. CURRENTLY (B)(6) (STERILIZATION DEPT.) TIGHTENS THE HANDPIECE SCREW PRIOR TO PACKAGING AND STERILIZING THE HANDPIECE, BUT THIS HAS NOT PROVEN TO FIX THE ISSUE. I HAVE BEEN TOLD THAT (B)(6) IS THE ONLY OR HAVING THIS ISSUE. I WOULD LIKE TO REACH OUT TO OTHER FACILITIES AND THEIR STERILIZATION DEPARTMENTS TO COMPARE THEIR PREPARATION PROCEDURES FOR THE MAKO HANDPIECE. POSSIBLY, WE ARE DOING SOMETHING DIFFERENT THAT CAUSES THE SCREW TO LOOSEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859790 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization