BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 7685491 · Received July 13, 2018

    Report

    Report Number
    3005985723-2018-00415
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    July 2, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT HANDLE POPPED OFF. THA CASE. 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: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K07U2. A REVIEW OF QT16-07-0090 SHOWS THAT THESE PARTS INITIALLY FAILED DUE TO NO CHARACTERIZATION DATA. DATA WAS LOADED AND THE UNITS WERE RE-INSPECTED ON 2/14/217 AND PUT ON (B)(4) FOR MISSING DOCUMENTATION. THIS UNIT WAS ACCEPTED INTO INVENTORY WHEN MISSING DOCUMENTS WERE PROVIDED. THE ISSUES WERE NOT RELATED TO THE COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO PARTS IN LOT NUMBER K07U2, P/N 209063 SHOWS 01 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT PR: (B)(4) CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. 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 POPPED OFF. THA 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 POPPED OFF. THA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530229 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. LOT #(S): 42020616SERIAL #(S 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization