BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 140MM, STERILE 2 PACK

    MDR report key: 7786670 · Received August 15, 2018

    Report

    Report Number
    3005985723-2018-00493
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    August 8, 2018
    Report Date
    November 2, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486018146
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: ONE OF THE 3.2X140 BONE PINS BROKE OFF IN THE FEMUR OF A PATIENT. SURGEON IS LEAVING THE TIP OF THE PIN IN THE PATIENT. SURGICAL DELAY = 15 MINUTES. CASE TYPE: PKA. 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 1674 DEVICES (NON STERILE P/N 143000-07) WERE MANUFACTURED UNDER LOT NO W50289 AND ACCEPTED INTO FINAL STOCK ON 02/28/17. 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 PR (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

    ONE OF THE 3.2X140 BONE PINS BROKE OFF IN THE FEMUR OF A PATIENT. SURGEON IS LEAVING THE TIP OF THE PIN IN THE PATIENT. SURGICAL DELAY = 15 MINUTES. CASE TYPE: PKA.

    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

    ONE OF THE 3.2X140 BONE PINS BROKE OFF IN THE FEMUR OF A PATIENT. SURGEON IS LEAVING THE TIP OF THE PIN IN THE PATIENT. SURGICAL DELAY- 15 MINUTES; CASE TYPE: PKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625193 BONE PIN, 3.2MM X 140MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W502891 00848486018146

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization