BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB, PT DRILL BIT WITH QUICK COUPLING, 2.5 MM

    MDR report key: 10413337 · Received August 17, 2020

    Report

    Report Number
    0009613350-2020-00378
    Event Type
    Injury
    Date Received
    August 17, 2020
    Date of Event
    July 22, 2020
    Report Date
    December 18, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LXH
    UDI-DI
    00889024289734
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2020, THE TIP OF THE DRILL BIT FRACTURED WHILE DRILLING SCREW HOLES FOR NCB PT PLATE. THE FRACTURED PORTION REMAINS IN THE PATIENT'S BONE. SHAFT PORTION OF THE DRILL ALSO FRACTURED. INVESTIGATION AND CONCLUSION HARM: S2 - TISSUE DAMAGE, MINOR. HAZARDOUS SITUATION: INSTRUMENT BREAKS, DIVERGES OR BECOMES DAMAGED AND NON-FUNCTIONAL DURING SURGICAL PROCEDURE. NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. NO RELEVANT MEDICAL DATA HAS BEEN RECEIVED. IT WAS REPORTED THAT A PIECE OF THE BROKEN DRILL REMAINED IN PATIENTS BODY. IN ACCORDANCE WITH ISO 10993-1 THE TRAUMA INSTRUMENTS GROUP 1: CUTTING AND DRILLING INSTRUMENTS ARE CATEGORIZED AS EXTERNAL COMMUNICATING DEVICES WITH TISSUE/BONE CONTACT FOR LESS THAN 24 HOURS (A ¿ LIMITED). VISUAL EXAMINATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. THE PRODUCT IS INTENDED FOR TREATMENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE IMAGE FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY THE TIP OF THE DRILL BIT WAS FRACTURED WHILE DRILLING SCREW HOLES AND THE FRACTURED PIECE HAS REMAINED IN THE PATIENT BONE. SHAFT PORTION OF THE DRILL ALSO FRACTURED. THE BROKEN PORTION WAS NOT ABLE TO BE RETRIEVED FROM THE PATIENT. THERE IS NO PLAN TO REMOVE IT BECAUSE THE PATIENT IS (B)(6) YEARS OLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881855 NCB, PT DRILL BIT WITH QUICK COUPLING, 2.5 MM NCB, PT DRILL BIT WITH QUICK COUPLING, 2.5 MM LXH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 413110 00889024289734

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization