BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8878868 · Received August 9, 2019

    Report

    Report Number
    3005985723-2019-00581
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Date of Event
    August 7, 2019
    Report Date
    February 27, 2020
    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

    SMALL SCREW SHEARED OFF FROM INSIDE MICS HANDLE IN BETWEEN CUTTING ATTACHMENTS DURING TKA. ANGLED ATTACHMENT WOULD NOT SLIDE IN, THEN SMALL SHEARED SCREW FELL OUT ONTO FLOOR. CASE TYPE: TKA. SURGICAL DELAY: = 15 MINUTES. UPDATE: "NO DEBRIS LEFT BEHIND AFTER CASE AFTER STRAIGHT SAW CUTTING ATTACHMENT WAS REMOVED, COULD NOT GET THE ANGLED ATTACHMENT. EVENTUALLY HE WAS ABLE TO GET IT IN AND COMPLETED CASE. PIECE OF DEBRIS WAS FOUND ON FLOOR BEFORE END OF CASE SAW ATTACHMENT CLICKED AND LOCKED IN." PRODUCT INSPECTION: AS PER SERVICE MAXWO-01993212 & CASE NUMBER (B)(4). RMA# (B)(4). SN# (B)(6). FACTORY SERVICE TECHNICIAN: (B)(4). 1. UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR). OTHER (RTV) FAILED COLLAR TEST. THE ALLEGED FAILURE WAS CONFIRMED. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K09GT AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 5/8/17. A REVIEW OF QT17-05-0034 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, LOT NUMBER 42030417 SHOWS 4 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: THE FAILURE MODE WAS CONFIRMED VIA INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 0

    SMALL SCREW SHEARED OFF FROM INSIDE MICS HANDLE IN BETWEEN CUTTING ATTACHMENTS DURING TKA. ANGLED ATTACHMENT WOULD NOT SLIDE IN, THEN SMALL SHEARED SCREW FELL OUT ONTO FLOOR. CASE TYPE: TKA. SURGICAL DELAY: = 15 MINUTES. UPDATE: "NO DEBRIS LEFT BEHIND AFTER CASE AFTER STRAIGHT SAW CUTTING ATTACHMENT WAS REMOVED, COULD NOT GET THE ANGLED ATTACHMENT. EVENTUALLY HE WAS ABLE TO GET IT IN AND COMPLETED CASE. PIECE OF DEBRIS WAS FOUND ON FLOOR BEFORE END OF CASE SAW ATTACHMENT CLICKED AND LOCKED IN."

    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

    SMALL SCREW SHEARED OFF FROM INSIDE MICS HANDLE IN BETWEEN CUTTING ATTACHMENTS DURING TKA. ANGLED ATTACHMENT WOULD NOT SLIDE IN, THEN SMALL SHEARED SCREW FELL OUT ONTO FLOOR CASE TYPE: TKA. SURGICAL DELAY: =15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672221 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 4202103 / 42030417 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization