BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQUARE SCREWDRIVER

    MDR report key: 9378968 · Received November 26, 2019

    Report

    Report Number
    3005985723-2019-00856
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 5, 2019
    Report Date
    February 3, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486002763
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: -CUSTOMER REPORTED THAT THE SILVER END OF SQUARE DRIVER CAME LOOSE FROM THE BLUE HANDLE WHILE TAKING APART ARRAYS/ARRAY CLAMPS. DEVICE EVALUATION AND RESULTS: DEVICE EVALUATION WAS PERFORMED AND THE SQUARE SCREWDRIVER EVENT WAS CONFIRMED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 379 DEVICES WERE MANUFACTURED AND INSPECTED ON 07-02-2018 WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: BASED ON THE DEVICE IDENTIFICATION, THE CATSWEB AND TRACKWISE COMPLAINT DATABASES WERE REVIEWED FROM 2011 TO PRESENT FOR SIMILAR REPORTED EVENTS REGARDING THE SQUARE SCREWDRIVER. THERE HAVE BEEN 50 OTHER EVENTS FOR THE REFERENCED LOT NUMBER. PRS # 1914925, 1919787, 1935822, 1943690, 1947954, 1953514, 1967031, 1970724, 1987510, 1978669, 1995528, 2001610, 2017816, 2018871, 2019846, 2022521, 2028928, 2030818, 2031968, 2036455, 2045046, 2045740, 2051183, 2073709, 2082053, 2103869, 2114279, 2114688, 2117018, 2122244, 2125456, 2127852, 2139397, 2149504, 215096, 2154940, 21666790, 2188146, 2188148, 2192078, 2204673, 2208809, 2209518, 2210264 , 2210272, 2211307, 2213526, 2221304, 2221688 AND 2228967 - WERE FOUND TO BE FROM THE SAME LOT AS THE PART IN THIS COMPLAINT. THE PARTS FROM THESE PRS DISPLAYED THE SAME FAILURE. CONCLUSIONS: THE SQUARE SCREWDRIVER SHOWED THE MASTERBOND THAT HOLDS THE SHAFT AND HANDLE CRACKED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT CAPA 1694870 WAS INITIATED FOR THIS PART NUMBER.

    Description of Event or Problem · 0

    SILVER END OF SQUARE DRIVER CAME LOOSE FROM THE BLUE HANDLE WHILE TAKING APART ARRAYS/ARRAY CLAMPS. CASE TYPE: PKA (ANSPACH). SURGICAL DELAY: > 30 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

    SILVER END OF SQUARE DRIVER CAME LOOSE FROM THE BLUE HANDLE WHILE TAKING APART ARRAYS/ARRAY CLAMPS. CASE TYPE: PKA (ANSPACH). SURGICAL DELAY: > 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172880 SQUARE SCREWDRIVER STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 111160 06110518 00848486002763

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization