BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8691182 · Received June 12, 2019

    Report

    Report Number
    3005985723-2019-00422
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 7, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT DURING BONE PREP THE MICS BROKE WHILE CUTTING... DR CORNELIUS PULLED IT OUT OF THE WOUND AND NOTICED AT THE LOCKING MECHANISM THERE WAS AN ISSUE. THE BALL BEARINGS, LOCKING MECHANISM ETC SEPARATED FROM THE MICS HANDPIECE. BALL BEARINGS AND SCREWS FROM INSIDE THE MICS SCATTERED ALL OVER THE FLOOR OF THE ROOM. PRODUCT EVALUATION AND RESULTS: AS PER WORK ORDER (B)(4) AND CASE NUMBER (B)(4) THE ALLEGED FAILURE MODE WAS CONFIRMED. UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR)" RTV REASON: COLLAR WAS NOT ATTACHED TO MICS. 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/"2017" AND PUT ON QT 17-02-0049 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 06 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 NC1414517 AND CAPA 1450904.

    Description of Event or Problem · 0

    DURING BONE PREP THE MICS BROKE WHILE CUTTING... DR (B)(6) PULLED IT OUT OF THE WOUND AND NOTICED AT THE LOCKING MECHANISM THERE WAS AN ISSUE. THE BALL BEARINGS, LOCKING MECHANISM ETC SEPARATED FROM THE MICS HANDPIECE. BALL BEARINGS AND SCREWS FROM INSIDE THE MICS SCATTERED ALL OVER THE FLOOR OF THE ROOM. CASE TYPE: TKA. SURGICAL DELAY: X - =15 MINUTES.

    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

    DURING BONE PREP THE MICS BROKE WHILE CUTTING. DR (B)(6) PULLED IT OUT OF THE WOUND AND NOTICED AT THE LOCKING MECHANISM THERE WAS AN ISSUE. THE BALL BEARINGS, LOCKING MECHANISM ETC SEPARATED FROM THE MICS HANDPIECE. BALL BEARINGS AND SCREWS FROM INSIDE THE MICS SCATTERED ALL OVER THE FLOOR OF THE ROOM. CASE TYPE: TKA. SURGICAL DELAY: X - =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485874 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42020616/4200785 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization