BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION PLATE 2 HOLE 30MM

    MDR report key: 6157850 · Received December 9, 2016

    Report

    Report Number
    9615741-2016-00064
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    November 17, 2016
    Manufacturer
    NEWDEAL SAS
    Product Code
    HRS
    PMA / PMN Number
    K093914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 5DEC2016. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF MANUFACTURING HISTORY RECORDS FOR THE RELATED PART NUMBER. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: DEVICE HISTORY RECORD FOR PN 330230SND LOT FEDT REVIEWED AND THE PICTURE OF THE DEVICE ON THE LABEL DOES NOT MATCH WITH THE DESIGNATION OF THE PRODUCT LIKE INDICATED IN THE DESCRIPTION OF THE COMPLAINT. A REVIEW OF THE COMPLAINT SYSTEM WAS PERFORMED. THIS IS THE FIRST INCIDENT REPORTED TO NEWDEAL ABOUT PICTURE ON LABEL NOT MATCHING WITH THE DESIGNATED UNI-CP¿ PLATE DURING LAST TWO YEARS. DURING THE SAME TIME PERIOD, 5046 UNI-CP¿ PLATES HAVE BEEN SOLD. THE COMPLAINT RATE FOR THIS KIND OF INCIDENT DURING THE STATED TIME PERIOD IS 0.019 PERCENT. CONCLUSION: GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT IS A HUMAN ERROR. THE PICTURE OF THE PRODUCT 330230SND LOT FEDT IS WRONG IN THE PLAN (B)(4). DURING THE IMPLEMENTATION OF UDI (UNIQUE DEVICE IDENTIFICATION) LABELLING, WE MADE OUR OWN LABELS FOR THE SUPPLIER WHICH PERFORMED THE PACKAGING. THE LABELLING IS BASED ON THE PLAN (B)(4) WHICH WAS NOT CONFORM TO THE PRODUCTS INDICATED IN THIS PLAN. THE LOT FEDT WAS MANUFACTURED IN OCTOBER 2015 BEFORE THE UPDATE OF THE PLAN (B)(4). THE PLAN (B)(4) WAS UPDATED AFTER DETECTION OF THE ERROR. THE NEW PLAN (B)(4) IS CONFORM AND USED BY OUR SUPPLIER PERFORMING THE PACKAGING OF OUR STERILE UNI-CP PLATES. WE OPEN AN INTERNAL NON-CONFORMANCE IN ORDER TO VERIFY THE PRODUCTS OF THE SAME FAMILY AND TO SECURE THE STOCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PICTURE ON THE PACKAGING SHOWS UNI CP 4 HOLE BUT THE REFERENCE ON THE PACKAGING IS UNI CP 2 HOLES. THE ISSUE WAS DETECTED BY THE SALES REPRESENTATIVE WHILE IMPLEMENTING CONSIGNMENT. THE CUSTOMER WAS NOT AWARE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811295 COMPRESSION PLATE 2 HOLE 30MM UNI-CP HRS NEWDEAL SAS FEDT

    Patients

    Seq Age Sex Outcome Treatment
    1