BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP ASSEMBLY- 3-PIN

    MDR report key: 7310980 · Received March 2, 2018

    Report

    Report Number
    3005985723-2018-00107
    Event Type
    Malfunction
    Date Received
    March 2, 2018
    Date of Event
    January 31, 2018
    Report Date
    May 23, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: IT WAS REPORTED THAT THE CLAMP WAS BROKEN DURING ASSEMBLY. 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 41 DEVICES WERE MANUFACTURED UNDER LOT NO 201543071402 AND ACCEPTED INTO FINAL STOCK ON 11/13/2017. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 112390, LOT NUMBER 201543071402 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: NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    WHEN PLACING THE 3 PIN CLAMP AND ADAPTER TO THE PINS, THE SCREW FROM THE ADAPTER BROKE INSIDE OF THE 3 PIN CLAMP. CASE TYPE THA.

    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

    WHEN PLACING THE 3 PIN CLAMP AND ADAPTER TO THE PINS, THE SCREW FROM THE ADAPTER BROKE INSIDE OF THE 3 PIN CLAMP. CASE TYPE THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152644 CLAMP ASSEMBLY- 3-PIN STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 201543071402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization