BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9584127 · Received January 13, 2020

    Report

    Report Number
    3005985723-2020-00029
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 16, 2019
    Report Date
    March 11, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: HANDLE LOCK IS BROKEN AND WOULD CONTINUE TO BREAK FREE AND HIT THE SURGEON IN THE HAND. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS NOT EVALUATED AS THE PRODUCT WAS UNAVAILABLE FOR INSPECTION. PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K06NY AND ACCEPTED INTO FINAL STOCK ON 3/22/2016. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063, PRODEX LOT K06NY SHOWS 03 ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: 1995101, 2133414, 2293384. CONCLUSIONS: THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. 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 AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    HANDLE LOCK IS BROKEN AND WOULD CONTINUE TO BREAK FREE AND HIT THE SURGEON IN THE HAND.... SO I NEED A REPLACEMENT MICS HANDPIECE SENT AS SOON AS POSSIBLE. THANK YOU! CASE TYPE: THA.

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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

    HANDLE LOCK IS BROKEN AND WOULD CONTINUE TO BREAK FREE AND HIT THE SURGEON IN THE HAND .... SO I NEED A REPLACEMENT MICS HANDPIECE SENT AS SOON AS POSSIBLE. THANK YOU! CASE TYPE: THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44350 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42020116 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other