BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT WITH QUICK COUPLING, 2-FLUTED, 2.5 MM, 154/180 MM

    MDR report key: 10419147 · Received August 18, 2020

    Report

    Report Number
    0009613350-2020-00383
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 1, 2020
    Report Date
    November 5, 2020
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HTW
    UDI-DI
    00889024298064
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: EVENT HAPPENED DURING THE SURGERY WHEN THE SURGEON NOTICED THAT THE DRILL BIT FRACTURED. THE FRACTURED PIECES WERE NOT REMOVED FROM THE PATIENT. REVIEW OF RECEIVED DATA: IMAGES: THE RECEIVED IMAGE WAS REVIEWED. IT CAN BE CONFIRMED THAT THE TIP OF THE DRILL IS BROKEN OFF. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DOCUMENT REVIEW COULD NOT BE PERFORMED DUE TO UNKNOWN PRODUCT IDENTIFICATION (LOT NUMBER UNKNOWN). DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. SURGICAL TECHNIQUE: THE SURGICAL TECHNIQUE FOR THE NCB DISTAL FEMUR WAS REVIEWED. IT IS MENTIONED THAT IN CASE OF GOOD BONE QUALITY IT IS RECOMMENDED TO DRILL THE CORTEX WITH A 4.3MM DRILL BIT. MOREOVER IN ALL FIGURES OF THE DRILLING PROCESS, A DRILLING PERPENDICULAR TO THE BONE SURFACE IS ILLUSTRATED. CONCLUSION: EVENT HAPPENED DURING THE SURGERY WHEN THE SURGEON NOTICED THAT THE DRILL BIT FRACTURED. THE FRACTURED PIECES WERE NOT REMOVED FROM THE PATIENT. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NONCONFORMANCE OR COMPLAINT OUT OF BOX (COOB). IT IS ADVISED TO MONITOR THE PATIENT, AS THE BROKEN OFF TIP REMAINED INSIDE THE PATIENT'S 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. 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 AVAILABLE NOW.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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. (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON NOTICED THAT THE DRILL BIT WAS FRACTURED. THE FRACTURED PIECES WERE NOT REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885792 DRILL BIT WITH QUICK COUPLING, 2-FLUTED, 2.5 MM, 154/180 MM DRILL BIT WITH QUICK COUPLING HTW ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN 00889024298064

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization