BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7660732 · Received July 3, 2018

    Report

    Report Number
    3005985723-2018-00404
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 28, 2018
    Report Date
    September 14, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT HANDLE FELL OFF THE HANDPIECE WHILE MAKING CUTS. PROCEEDED WITHOUT HANDLE FOR REMAINING CUTS. TKA CASE. PRODUCT EVALUATION AND RESULTS: "VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE. THE HANDLE WAS PROPERLY ATTACHED TO THE HANDPIECE WHEN INVESTIGATED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED. THE REPORTED PROBLEM WAS A FUNCTIONAL ISSUE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS FUNCTIONAL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION REVEALED NO PHYSICAL DAMAGE AND THE PRODUCT FUNCTIONED AS INTENDED. " PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K0AES AND (B)(4) INCLUDING 4203055 WERE ACCEPTED INTO FINAL STOCK ON 10/30/2017.NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 209063,PRODEX LOT K0AES SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE COULD NOT DE DUPLICATED. 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 (B)(4) AND CAPA (B)(4).

    Description of Event or Problem · 0

    HANDLE FELL OFF THE HANDPIECE WHILE MAKING CUTS. PROCEEDED WITHOUT HANDLE FOR REMAINING CUTS. TKA CASE.

    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

    HANDLE FELL OFF THE HANDPIECE WHILE MAKING CUTS. PROCEEDED WITHOUT HANDLE FOR REMAINING CUTS. TKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501846 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4203055 / 42051017 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization