BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 8487538 · Received April 5, 2019

    Report

    Report Number
    0001038806-2019-00288
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    February 25, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    HWC
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION: 0001038806-2019-00287-1 AND 0001038806-2019-00270-1 HAVE ALSO BEEN SUBMITTED. THE FOLLOWING SECTIONS ARE BEING REPORTED: IT WAS REPORTED THAT THE PROSTHETIC SCREW FRACTURED. THE FRACTURED PORTION WAS NOT ABLE TO BE REMOVED FROM THE IMPLANT. THE IMPLANT WAS REMOVED. THERE WAS NO REPORT OF PATIENT INJURY. DATE RETURNED TO MFR: 01 JUL 2019. REPORT TYPE: FOLLOW UP. FOLLOW UP TYPE: SERIOUS INJURY. THE REPORTED DEVICE AND CONCOMITANT DEVICE WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICES REVEALED THAT THE INTERNAL DRIVE FEATURE OF THE IMPLANT CONTAINED PIECES OF THE REPORTED SCREW, WHICH WERE TOO BADLY DAMAGED TO BE REMOVED. THE REPORTED CONDITION OF A FRACTURED SCREW THAT WAS NOT ABLE TO BE REMOVED FROM THE IMPLANT WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW AND COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED FOR THE REPORTED SCREW AS THE DEVICE ITEM AND LOT ARE UNKNOWN. A DHR REVIEW WAS COMPLETED FOR THE REPORTED CONCOMITANT IMPLANT. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED CONCOMITANT IMPLANT FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. 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. FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROSTHETIC SCREW FRACTURED. THE FRACTURED PORTION WAS NOT ABLE TO BE REMOVED FROM THE IMPLANT. THE IMPLANT WAS REMOVED. THERE WAS NO REPORT OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT INFORMATION: PATIENT INFORMATION NOT PROVIDED/UNKNOWN. COMMON DEVICE NAME: DEVICE BRAND NAME NOT PROVIDED/UNKNOWN. PROCODE: DEVICE PRODUCT CODE UNKNOWN. CATALOG #, LOT #: DEVICE CATALOG AND LOT NUMBER NOT PROVIDED/UNKNOWN. REPORTER: REPORTER'S EMAIL NOT PROVIDED/UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN BIOMET SCREW FRACTURED INSIDE OF THE IMPLANT. THE IMPLANT HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281148 SCREW HWC BIOMET 3I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention XIFNT410| XIFNT410