BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PIN, 3.2MM X 80MM, STERILE 2 PACK

    MDR report key: 7970485 · Received October 16, 2018

    Report

    Report Number
    3005985723-2018-00602
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 24, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486018122
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT 3.2MM MAKO PIN TIP BROKE OFF IN PATIENT TIBIA WHILST REMOVING PIN AT END OF MARKO. PRODUCT EVALUATION AND RESULTS: THE PRODUCT WAS UNAVAILABLE FOR INSPECTION AS THE PRODUCT WAS NOT RETURNED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT NO W50959-1 AND ACCEPTED INTO FINAL STOCK ON 07/10/2017. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 143080, LOT NUMBER W50959-1 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. 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 HAVE BEEN 01 NCS (B)(4) AND CAPAS 1480798 ARE ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    3.2MM MAKO PIN TIP BROKE OFF IN PATIENT TIBIA WHILST REMOVING PIN AT END OF MAKO TKA CASE.

    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

    3.2MM MAKO PIN TIP BROKE OFF IN PATIENT TIBIA WHILST REMOVING PIN AT END OF MAKO TKA CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809874 BONE PIN, 3.2MM X 80MM, STERILE 2 PACK STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. W50959-1 00848486018122

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization