BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCB, DRILL GUIDE, 4.3 MM

    MDR report key: 10619093 · Received October 2, 2020

    Report

    Report Number
    0009613350-2020-00445
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Date of Event
    September 3, 2020
    Report Date
    February 3, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    FZX
    UDI-DI
    00889024289321
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: IT WAS REPORTED THAT ON SEP 3, 2020, THE DRILL GOT STUCK IN THE DRILL GUIDE. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION (DRILL BIT AND DRILL GUIDE) WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION. CONCLUSION: IT WAS REPORTED THAT ON SEP 3, 2020, THE DRILL GOT STUCK IN THE DRILL GUIDE. 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). THE DEVICE WAS NOT RETURNED FOR EXAMINATION, THEREFORE, AN INVESTIGATION COULD NOT BE PERFORMED, HENCE AN EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: NCB, DRILL BIT, 4.3 MM, 195 MM CATALOG #: 02.00024.002 LOT #: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350- 2020-00444.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRILL GOT STUCK IN THE DRILL GUIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE IMPLANTATION AND EXPLANTATION DATES ARE LEFT EMPTY AS THE DEVICE INVOLVED IN THIS COMPLAINT IS AN INSTRUMENT. HENCE, NO EXPIRATION DATE IS CAPTURED, FOR THE SAME REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082880 NCB, DRILL GUIDE, 4.3 MM N/A FZX ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN 00889024289321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other