BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 110MM, STERILE 2 PACK

    MDR report key: 7888887 · Received September 19, 2018

    Report

    Report Number
    3005985723-2018-00539
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 30, 2018
    Report Date
    October 23, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486018139
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: A SMALL PIECE OF A TIBIAL PIN 3.2X110 REF 143110 LOT W53978-1 BLOKE AND REMAINED IN THE PATIENT¿S TIBIA. DEVICE EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 2536 DEVICES WERE MANUFACTURED UNDER LOT NO W53978 AND ACCEPTED INTO FINAL STOCK ON 09/22/2017. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, L/N W47865 SHOWS 3 ADDITIONAL COMPLAINTS UNDER INVESTIGATION RELATED TO THE FAILURE IN THIS INVESTIGATION. THESE PRS ARE (B)(4). CONCLUSIONS: THE FAILURE MODE COULD NOT BE CONFIRMED BECAUSE THE PART WAS NOT AVAILABLE FOR EVALUATION. IF DEVICE AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAS BEEN ONE NC AND 2 CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THE NC AND CAPAS ARE NC 1470754 CAPA 1480798 CAPA 301. ONE CAPA HAS BEEN COMPLETED (CATSWEB SYSTEM IS CAPA 301) WHILE THE SECOND IS STILL OPEN (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    A SMALL PIECE OF A TIBIAL PIN 3.2X110 REF 143110 LOT W53978-1 BLOKE AND REMAINED IN THE PATIENT¿S TIBIA.

    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

    A SMALL PIECE OF A TIBIAL PIN 3.2X110 REF 143110 LOT W53978-1 BLOKE AND REMAINED IN THE PATIENT¿S TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732955 BONE PIN, 3.2MM X 110MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W53978-1 00848486018139

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization