BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8871211 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00567
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: MISSING ADJUSTMENT TAB, WAS UNABLE TO ADJUST HANDLE WHILE USING THE SAW, BUT FINISHED CUTS WITHOUT ADJUSTING. PRODUCT EVALUATION AND RESULTS: FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS PERFORMED AND CONFIRMED THAT THERE WAS A FAILED PIVOT HANDLE CHECK. ATTEMPTS TO REPAIR WERE UNSUCCESSFUL. VISUAL INSPECTION, DIMENSIONAL INSPECTION AND MATERIAL ANALYSIS. ANALYSIS WERE NOT PERFORMED AS FUNCTIONAL INSPECTION CONFIRMED THE FAILURE. PER (B)(4) AND 04054882 PART WAS RTV FOR REWORK. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0B19 AND ALL DEVICES WERE ACCEPTED INTO FINAL STOCK ON 04/04/2018. NO NON-CONFORMANCE WAS IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, S/N 4203811 IN PRODEX LOT K0B19 SHOWS 01 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: 1958754 CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC/CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    MISSING ADJUSTMENT TAB, WAS UNABLE TO ADJUST HANDLE WHILE USING THE SAW, BUT FINISHED CUTS WITHOUT ADJUSTING CASE TYPE: TKA.

    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

    MISSING ADJUSTMENT TAB, WAS UNABLE TO ADJUST HANDLE WHILE USING THE SAW, BUT FINISHED CUTS WITHOUT ADJUSTING. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663631 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42050318 / 4203808 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization