BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90° CONTRA ANGLE DRIVER

    MDR report key: 8634370 · Received May 22, 2019

    Report

    Report Number
    0001032347-2019-00289
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 12, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    UDI-DI
    00841036123130
    PMA / PMN Number
    K142823
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (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. CONCOMITANT MEDICAL PRODUCTS - ZIMMER BIOMET TRAUMAONE SYSTEM CONTRA ANGLE CROSS-DRIVE BLADE CATALOG #: SP-2379 LOT #: NI; ZIMMER BIOMET RIBFIX BLU SYSTEM TEMPORARY FIXATION SCREW, CONTRA ANGLE CATALOG #: 76-0017 LOT #: NI. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2019-00290.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORIF OF FRACTURED RIBS THE DRIVERS EITHER STRIPPED OR PINS BECAME STUCK IN THE DRIVERS. ONE PIN BECAME STUCK IN THE DRIVER DURING USE ON THE PATIENT'S FOURTH RIB AND IN AN ATTEMPT TO FREE THE PIN, THE SURGEON PULLED ON THE DRIVER CAUSING THE TEMPORARY PIN TO PULL AND STRIP THE PATIENT'S BONE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425551 90° CONTRA ANGLE DRIVER SCREWDRIVER HRS BIOMET MICROFIXATION N/A UNK 00841036123130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention