BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAVLIK HARNESS, SMALL

    MDR report key: 5135852 · Received October 8, 2015

    Report

    Report Number
    1526350-2015-00172
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    June 1, 2014
    Report Date
    September 7, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    IOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 24503 NOTED NO RELEVANT ISSUES. TWO SAMPLES EACH FROM CURRENT INVENTORY OF THE 00-1716-010-00 SMALL HARNESS AND THE 00-1716-011-00 MEDIUM HARNESS WERE EVALUATED. THE BUCKLES WERE REVIEWED AND COMPARED TO THE APPROVED SAMPLE AND NO ISSUES WERE NOTED. THE CUSTOMER'S REPORTED EVENT OF POOR BUCKLE QUALITY CANNOT BE CONFIRMED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE MANUFACTURING PROCESS, DHR AND SPECIFICATIONS DO NOT INDICATE ANY SYSTEMIC ISSUES. THE CONDITIONS OF THE DEVICES OR THE ORIGINAL SHIPPING CONTAINERS ARE UNKNOWN. ADDITIONALLY, THE STORAGE CONDITIONS AND HANDLING PROCESS IS UNKNOWN. SPECULATING, THE MOST LIKELY CAUSE FOR THE BUCKLES BREAKING IS HANDLING OR IN TRANSIT DAMAGE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE BUCKLE ON THE HARNESS BROKE AND COULD HAVE SERIOUSLY HURT THE BABY. ANOTHER DEVICE WAS THEN CHECKED WAS ALSO FOUND TO BE OF A VERY POOR STANDARD. ADDITIONAL CLINICAL INFORMATION CLARIFIED THAT THE BABY WAS PUT INTO A HARNESS IN (B)(6) 2014 AT (B)(6) OF AGE AND THE PROBLEM OF THE BUCKLE BENDING OUT OF SHAPE WAS NOTED WITHIN THE FIRST 4 WEEKS. THE BUCKLE GOT CAUGHT IN THE CELLULAR BLANKET - WHEN THE PARENT WENT TO LIFT THE BABY UP, THE BUCKLE WAS PULLED OUT OF SHAPE BY THE TRACTION FORCE OF THE BLANKET. THE HARNESS WAS REPLACED THE FOLLOWING DAY AND THE BABY WAS PLACED IN A SIZE SMALL PAVLIK HARNESS AND ALL THE BUCKLES WERE TAPED DOWN TO PREVENT ANY DISTORTION. WHEN THE TAPE WAS REMOVED FROM AROUND THE BUCKLE, THE PHYSIOTHERAPIST WAS STABBED BY THE SPEARS OF THE RIGHT SHOULDER STRAP. BLOOD DROPLETS FELL ONTO AND SOILED THE HARNESS AND IT HAD TO BE REMOVED FROM THE BABY. NO FURTHER ISSUES OCCURRED WITH THE REPLACEMENT HARNESS. ADDITIONAL CLARIFICATION RECEIVED ON 9/7/15 INDICATED THAT THE ISSUE OCCURRED WHEN THE METAL CAPPING SYSTEM THAT COVERS THE SHARP END OF THE SPEARS AT THE BUCKLE OF THE RIGHT SHOULDER STRAP. THE SPEARS HAD PENETRATED THROUGH THE MATERIAL OF THE STRAP, LAY EXPOSED TO THE SKIN OF THE CHILD'S THORAX AND THE PHYSIOTHERAPIST RECEIVED A STAB WOUND TO THE LEFT MIDDLE FINGER. THERE WAS NO INJURY TO THE BABY REPORTED. THERE WAS NO MEDICAL TREATMENT/INTERVENTION GIVEN TO THE PHYSIOTHERAPIST. IT WAS STATED THAT THE INCIDENT WAS NOT REPORTED TO INFECTION CONTROL AS THE WOUND WAS NOT CONSIDERED A NEEDLE STICK OR SHARPS INJURY AND THE PHYSIOTHERAPIST STATED THAT HER TETANUS AND HEPATITIS B VACCINATIONS WERE BOTH UP TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669646 PAVLIK HARNESS, SMALL PAVLIK HARNESS, SMALL IOZ ZIMMER SURGICAL 24503

    Patients

    Seq Age Sex Outcome Treatment
    1