BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIC LIP AND CHEEK SELF-RETAINING RETRACTOR, SELF RETAINING, CHILD SIZE

    MDR report key: 7228189 · Received January 30, 2018

    Report

    Report Number
    0001032347-2018-00052
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    May 18, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EIG
    PMA / PMN Number
    PN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE PRODUCT CODE: EIG. (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PARTS IN STOCK. TWO PARTS FROM STOCK FROM THE SAME LOT WERE REVIEWED AND CONFIRMED THAT THE PACKAGED PARTS WERE THE INCORRECT SIZE. IT WAS DETERMINED THAT AN INCORRECT PART WAS SUPPLIED BY THE VENDOR, AS THE EXPECTED PART WAS 09-0136, BUT THE PHYSICAL PART WAS 09-0135. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO OPERATOR ERROR DURING THE PACKAGING PROCESS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE EVALUATED BY MANUFACTURER AND NOT RETURNED TO MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED EIGHT PACKAGES FOR CHILD-SIZED LIP RETRACTORS CONTAINED LIP RETRACTORS THAT WERE TOO LARGE. THIS WAS IDENTIFIED UPON RECEIPT. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73042 PLASTIC LIP AND CHEEK SELF-RETAINING RETRACTOR, SELF RETAINING, CHILD SIZE RETRACTOR; DENTAL HAND INSTRUMENT EIG BIOMET MICROFIXATION N/A 100025169

    Patients

    Seq Age Sex Outcome Treatment
    1