BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANSPACH HD LONG ATTACHMENT

    MDR report key: 6522055 · Received April 26, 2017

    Report

    Report Number
    3005985723-2017-00195
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    April 24, 2017
    Report Date
    June 19, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE EVENT REPORTED THAT AN ANSPACH HD LONG ATTACHMENT LOUD NOISE DURING BURRING AND OVERHEATING OCCURRED BURNING THE SURGEON'S FINGER. A DELAY OF 10 MINUTES OCCURRED. DEVICE EVALUATION AND RESULTS: THE ANSPACH HD LONG ATTACHMENT WAS BENCH EVALUATED USING A KNOWN GOOD ANSPACH MOTOR, ANSPACH FOOT SWITCH, BURR TOOL AND ANSPACH CONSOLE AND ALL TESTING SUCCESSFUL AND THE ERROR COULD NOT BE DUPLICATED. NO OVERHEATING OR AUDIBLE NOISE OCCURRED. DEVICE HISTORY REVIEW: NOT PERFORMED AS THE ANSPACH HD LONG ATTACHMENT IS AN OEM PRODUCT. COMPLAINT HISTORY REVIEW: REVIEW OF COMPLAINTS FOR P/N 110920, S/N (B)(4) SHOWED NO OTHER COMPLAINTS WITHIN THE TRACKWISE DATABASE. CONCLUSION: THE FAILURE COULD NOT BE DUPLICATED. THE OVERHEATING OF THE HD LONG ATTACHMENT COULD BE DUE TO THE ANSPACH MOTOR OVERHEATING AND TRANSFERRING THERMAL ENERGY TO THE HD LONG ATTACHMENT. 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.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE LONG HD SOUNDED HIGH PITCH DURING BURRING AND HEATED UP ENOUGH TO BURN THE SURGEON'S FINGER.

    Description of Event or Problem · 1

    THE SURGEON WAS COMPLETING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM. THE LONG HD SOUNDED HIGH PITCH DURING BURRING AND HEATED UP ENOUGH TO BURN THE SURGEON'S FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305524 ANSPACH HD LONG ATTACHMENT STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. SNF44307062101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other