BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    90 DEGREE CONTRA ANGLE SCREWDRIVER

    MDR report key: 6138195 · Received December 1, 2016

    Report

    Report Number
    0001032347-2016-00726
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 11, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT IDENTITY WAS CONFIRMED IN THE EVALUATION. THE DRIVER WAS VISUALLY EVALUATED AND SHOWS SIGNS OF NORMAL USE. THE DRIVER WAS TESTED AND FOUND TO FUNCTION AS INTENDED WITH NO ISSUES. THEREFORE, THE COMPLAINT IS UNCONFIRMED. THE MOST-LIKELY CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED AS NO ISSUE WAS FOUND. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS FOR MANUFACTURING DEFECTS.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS SUBMITTED TO CORRECT THE DEVICE PRODUCT CODE AND 510(K) NUMBER. THE FOLLOWING SECTIONS WERE CORRECTED: DEVICE PRODUCT CODE: JEY CORRECTED TO HRS. PMA/510(K) NUMBER: K121589 CORRECTED TO K142823. (B)(4).

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A CONTRA ANGLE DRIVER THAT DID NOT FUNCTION DURING A PROCEDURE. IT WAS REPORTED THE DRIVER APPEARED TO BE STRIPPED. IT WAS REPORTED THE SURGEON USED THE AVAILABLE SPARE DRIVER. IT WAS REPORTED THERE WAS A TWO MINUTE DELAY TO EXCHANGE THE DRIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790085 90 DEGREE CONTRA ANGLE SCREWDRIVER SCREW DRIVER HRS BIOMET MICROFIXATION N/A 465660

    Patients

    Seq Age Sex Outcome Treatment
    1