BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL, CHECKPOINT, STERILE

    MDR report key: 9511707 · Received December 23, 2019

    Report

    Report Number
    3005985723-2019-00916
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Date of Event
    November 27, 2019
    Report Date
    February 25, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486001353
    PMA / PMN Number
    K112507
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: TIBIA CHECKPOINT TIP BROKE OFF IN PATIENT WHILE EXTRACTING. TIP REMAINING IN PATIENT IS ROUGHLY 2 MM. CASE TYPE: THA. SURGICAL DELAY: = 15 MINUTES. 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 09 DEVICES WERE MANUFACTURED UNDER LOT NO W60117-1. AND ACCEPTED INTO FINAL STOCK ON 01/03/2012. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 111651, L/N W60117-1 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE EVENT WAS NOT CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. THE FAILURE COULD NOT BE DETERMINED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    TIBIA CHECKPOINT TIP BROKE OFF IN PATIENT WHILE EXTRACTING. TIP REMAINING IN PATIENT IS ROUGHLY 2 MM. CASE TYPE: THA. SURGICAL DELAY: = 15 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

    TIBIA CHECKPOINT TIP BROKE OFF IN PATIENT WHILE EXTRACTING. TIP REMAINING IN PATIENT IS ROUGHLY 2 MM. CASE TYPE: THA. SURGICAL DELAY: = 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304440 TIBIAL, CHECKPOINT, STERILE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 111651 W60117-1 00848486001353

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other