BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQUARE DRILL ADAPTOR

    MDR report key: 8871150 · Received August 7, 2019

    Report

    Report Number
    3005985723-2019-00562
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 26, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002725
    PMA / PMN Number
    K121064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT SURGEON WAS TAKING OUT TIBIA BONE PINS AND METAL PIECE FELL OUT OF DRILL. ONCE WE INSPECTED THE DRILL WE SAW THE METAL SIDE ON DRILL HAD BROKEN PRODUCT EVALUATION AND RESULTS: FROM IMAGE PROVIDED: THE SQUARE DRILL ADAPTOR SHOWED ONE OF THE PRONGS FOR HOLDING THE PINS BROKEN OFF. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 165 DEVICES WERE MANUFACTURED UNDER LOT NO 06070717 AND ACCEPTED INTO FINAL STOCK ON (B)(6) 2017 VIA QT17- 07-0080. REVIEW OF QT17-07-0080 REVEALED THAT THE NONCONFORMANCE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063 LOT NUMBER 06070717 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: AS PER ATTACHED PICTURE THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT THERE HAVE BEEN NO NC¿S ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    SURGEON WAS TAKING OUT TIBIA BONE PINS AND METAL PIECE FELL OUT OF DRILL. ONCE WE INSPECTED THE DRILL WE SAW THE METAL SIDE ON DRILL HAD BROKEN. CASE TYPE: TKA. UPDATE: "THE PATIENT WAS UNDER ANESTHESIA."

    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

    SURGEON WAS TAKING OUT TIBIA BONE PINS AND METAL PIECE FELL OUT OF DRILL. ONCE WE INSPECTED THE DRILL WE SAW THE METAL SIDE ON DRILL HAD BROKEN. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664107 SQUARE DRILL ADAPTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 06070717 00848486002725

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization