BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ¿GLENOSPHERE REMOVAL HANDLE MOD¿

    MDR report key: 7108395 · Received December 12, 2017

    Report

    Report Number
    1651501-2017-00045
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER HAS NOT BEEN IDENTIFIED FOR PRODUCT ID HDL-0960-067-01 AND A MANUFACTURING RECORDS REVIEW COULD NOT BE CONDUCTED. A REVIEW OF COMPLAINT RECORDS SHOWED THAT IN THE LAST 5 YEARS, 1 COMPLAINT HAS BEEN RECEIVED FOR THE GLENOSPHERE REMOVAL HANDLE. THIS REPRESENTS 0.03% (1/3052) COMPLAINT RATE. AN ADVERSE TREND IS NOT IDENTIFIED. THE SURGICAL TECHNIQUE STATES TO REMOVE THE IN SITU GLENOSPHERE, THE GLENOSPHERE REMOVAL HANDLE IS FULLY THREADED INTO THE IN SITU GLENOSPHERE TO RELEASE THE TAPER LOCK OF THE GLENOSPHERE FROM THE BASEPLATE. DEPENDING ON THE SCREW SIZE, EITHER THE REMOVAL TOOL CAN PUSH THE TWO COMPONENT APART OR A SLOTTED MALLET IS USED TO DISENGAGE THE GLENOSPHERE FROM THE BASEPLATE WITH GENTLE STRIKES. THE SURGICAL TECHNIQUE SPECIFICALLY STATES THE REMOVAL HANDLE WILL NOT WORK IF A 5.5 MM CENTRAL SCREW IS USED. AS THE COMPONENT SATISFIED ALL APPLICABLE MANUFACTURING SPECIFICATIONS AND INSPECTION CRITERIA AND NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECORDED, A ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL CAUSES OF THE FAILURE MODE MAY HAVE RESULTED FROM HIGH INCLINATION ANGLE LOADING OR IMPROPER TECHNIQUE SUCH WAS USING THE TOOL WITH THE 5.5 MM CENTRAL SCREW.

    Description of Event or Problem · 1

    THE INSTRUMENT BROKE OFF INSIDE IN-SITU IMPLANT AS THE SURGEON WAS USING THE INSTRUMENT AS INTENDED; TO REMOVE A GLENOSPHERE FROM IN-SITU BASEPLATE. THE REMAINING PART WAS LODGED INSIDE THE GLENOSPHERE IMPLANT BUT THE SURGEON WAS ABLE TO PROCEED REMOVING THE GLENOSPHERE WITH AN ALTERNATIVE TECHNIQUE. THE SALES REPRESENTATIVE STATED THE BROKEN PIECES WERE NOT AVAILABLE TO BE SENT BACK TO INTEGRA AS THE HOSPITAL STAFF HAD ALREADY DISCARDED THEM. AN IMAGE OF THE INSTRUMENT SHOWED IT BROKE OFF AT THE THREADED DISTAL TIP. THERE WAS NO PATIENT INJURY. DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM WAS REPORTED AS 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889174 ¿GLENOSPHERE REMOVAL HANDLE MOD¿ TITAN SHOULDER SYSTEM LXH ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1