BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREWDRIVER

    MDR report key: 7321196 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01711
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    August 5, 2013
    Report Date
    June 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWY
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: 113848, ITEM NAME: TITANIUM LOW PROFILE SCREW, LOT #: 471120. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES PROVIDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. COMPLAINT HISTORY REVIEW ALSO COULD NOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROPLASTY REVISION SURGERY, THE TIP OF A SCREWDRIVER FRACTURED OFF INTO A SCREW WHILE REMOVING THE SCREW FROM THE CUP. THE CUP WAS LOOSENED WITH OSTEOTOMES AND REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164848 UNKNOWN SCREWDRIVER PROSTHESIS, HIP KWY ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR