BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NCB, DF TORQUE SCREWDRIVER, 6 NM, 280 MM

    MDR report key: 12959509 · Received December 8, 2021

    Report

    Report Number
    0009613350-2021-00656
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    October 15, 2021
    Report Date
    January 20, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HRS
    UDI-DI
    00889024289338
    PMA / PMN Number
    K192217
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED PHOTOGRAPHS WHICH WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED THAT THE HEX PART OF THE SCREWDRIVER WAS STRIPPED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. VISUAL EXAMINATION: THE INSTRUMENT SHOWS SIGNS OF USAGE. THE HEXAGONAL TIP IS SLIGHTLY DEFORMED. THE DEVICE WAS MANUFACTURED IN 2015. IT CAN BE ASSUMED THAT THE INSTRUMENT WAS IN USE FOR SEVERAL TIMES. THE PRODUCT IS INTENDED FOR TREATMENT. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IT IS POSSIBLE THAT THE INSTRUMENT WAS NOT USED CORRECTLY. THE WHOLE HEXAGONAL PART HAS TO BE INSERTED IN THE SCREW HOLE TO AVOID ANY DAMAGES ON THIS AREA. HOWEVER, BASED ON THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE. 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

    IT WAS REPORTED THAT A SCREW DRIVER IS STRIPPED AND LOSES BITE.

    Description of Event or Problem · 0

    INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860075 NCB, DF TORQUE SCREWDRIVER, 6 NM, 280 MM NCB PLATING SYSTEM DISTAL FEMUR AND PROXIMAL TIBIA HRS ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 15160127 00889024289338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown