BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIABLE PITCH COMPRESSION SCREW 2.5X16MM

    MDR report key: 7591980 · Received June 12, 2018

    Report

    Report Number
    0001825034-2018-03908
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    PK160058
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. MEDICAL PRODUCT - K-WIRE COCR 0.9 X 95MM, CAT#: 231209095 LOT#: NI, MAX VPC CANN DRILL 1.8MM, CAT#: 231201025 LOT#: NI, K-WIRE COCR 1.1 X 105MM, CAT#: 231211105 LOT#: NI, MAX VPC CANN DRILL 2.4MM, CAT#: 231201030 LOT#: NI, VPC SCREW 3.4X16MM, CAT#: 233230016 LOT#: NI. PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT WAS RETURNED AND VISUALLY EXAMINED, CONFIRMING THE REPORTED EVENT. THERE IS DAMAGE OBSERVED TO THE FIRST 6 THREADS OF THE SCREW AND THE HEAD IS BADLY DAMAGED. REVIEW OF DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE NECESSARY PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS NOTED THAT THE PATIENT WAS YOUNG AND HAD HARD BONE WHICH MAY HAVE CONTRIBUTED TO THE EVENT. 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). PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 WAS REPORTED THAT DURING THE PROCEDURE, WHILE IMPLANTING A SECOND SCREW INTO THE RADIAL HEAD, THE SCREW STRIPPED DURING INSERTION AND HAD TO BE REMOVED. A NEW DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS A THIRTY (30) MINUTE DELAY TO THE PROCEDURE. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433156 VARIABLE PITCH COMPRESSION SCREW 2.5X16MM SCREW, FIXATION HWC ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention