BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7660733 · Received July 3, 2018

    Report

    Report Number
    3005985723-2018-00405
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 22, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT THE HANDLE FELL OFF OF THE MICS HANDPIECE IN BETWEEN SAW CUTS. PRODUCT EVALUATION AND RESULTS: "VISUAL INSPECTION: VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE OF UNIT. THE SCREW WAS OUTSIDE OF THE UNIT AND THE HANDLE HAD DISLOCATED. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS NOT COMPLETED VISUAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. MATERIAL ANALYSIS: MATERIAL ANALYSIS WAS NOT COMPLETED BECAUSE THE FAILURE WAS VISUAL. FUNCTIONAL INSPECTION: THE HANDPIECE MOTOR AND ELECTRONICS FUNCTION AS INTENDED." PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT: K0A8H AND 21 INCLUDING 4202840 WERE ACCEPTED INTO FINAL STOCK ON 9/29/2017. A REVIEW OF QT17-09-0071 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N: 209063, PRODEX LOT: K0A8H SHOWS NO ADDITIONAL COMPLAINT(S) RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRM. 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

    THE HANDLE FELL OFF OF THE MICS HANDPIECE IN BETWEEN SAW CUTS. THIS ISSUE WAS CAUGHT BEFORE ANY PATIENT INVOLVEMENT. TKA CASE DELAYED APPROXIMATELY 2 MINUTES.

    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

    THE HANDLE FELL OFF OF THE MICS HANDPIECE IN BETWEEN SAW CUTS. THIS ISSUE WAS CAUGHT BEFORE ANY PATIENT INVOLVEMENT. TKA CASE DELAYED APPROXIMATELY 2 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501847 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 4202840 / 42020917 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization