BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 20MM

    MDR report key: 7744109 · Received August 2, 2018

    Report

    Report Number
    3006460162-2018-00058
    Event Type
    Malfunction
    Date Received
    August 2, 2018
    Date of Event
    June 19, 2018
    Report Date
    November 22, 2019
    Manufacturer
    ORTHOPEDIATRICS, INC
    Product Code
    HWC
    PMA / PMN Number
    K100240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: H6 UPDATED METHOD 4110 AND 4114. H6 UPDATED RESULTS 3211. H6 UPDATED CONCLUSION 4315. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO PHOTOS WERE SUBMITTED FOR EVALUATION. THE LOT NUMBER WAS NOT PROVIDED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - ITEM: 00-1200-3503, 90 DEGREE LOCKING CANNULATED CHILD BLADE, 40MM X 6MM X 3-HOLE, LOT: UNKNOWN; ITEM: 00-0903-2522, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 22MM, LOT: UNKNOWN; ITEM: 00-0903-2520, 3.5MM SELF TAPPING CORTICAL SCREW, T15 HEX, SIZE 20MM, LOT: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT HAS BEEN DISCARDED AT THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT DURING THE PLANNED REMOVAL OF A FEMORAL BLADE PLATE AND THREE SCREWS, IT WAS DISCOVERED THAT THE MIDDLE SCREW WAS COLD-WELDED TO THE PLATE. THE SURGEON ATTEMPTED TO REMOVE THE SCREW WITH TWO DIFFERENT DRIVERS AND A BROKEN SCREW REMOVAL KIT BUT WAS UNSUCCESSFUL. HE THEN USED A BURR TO REMOVE THE HEAD OF THE SCREW AND WAS ABLE TO REMOVE THE PLATE. THE WOUND WAS IRRIGATED WITH SALINE TO REMOVE THE METAL SHAVINGS. THE MALFUNCTION ADDED THIRTY MINUTES TO THE PATIENT'S SURGERY TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583581 ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, SIZE 20MM SCREW FIXATION BONE HWC ORTHOPEDIATRICS, INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10