BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX DRIVER SHOULDER FAST

    MDR report key: 6903647 · Received September 29, 2017

    Report

    Report Number
    0001825034-2017-07453
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    June 4, 2015
    Report Date
    September 29, 2017
    Manufacturer
    3-D MACHINING INC.
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND PRODUCT WAS MADE TO PRINT AND CORRECT MATERIALS. PRODUCT LEFT CONFORMING TO PRINT AS THERE WAS NO EVIDENCE THAT STATES OTHERWISE. AFTER REVIEWING COMPLAINT AND CONDITION OF COMPLAINT PRODUCT AS RETURNED, THE HEX DRIVER¿S TIP HAD FRACTURED AS STATED IN THE COMPLAINT. THIS FAILURE LIKELY OCCURRED DUE TO EXCESSIVE FORCE OR TORQUE. THIS WAS NOT A SUPPLIER ISSUE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION: UNDER LINE 202: "DRIVER TIP BREAKS DURING USE." ZIMMER BIOMET COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROXIMAL HUMERAL OPEN REDUCTION INTERNAL FIXATION PROCEDURE, THE TIP OF THE HEX DRIVER FRACTURED OFF AS THE SURGEON WAS INSERTING A SCREW, ANOTHER DRIVER WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682963 HEX DRIVER SHOULDER FAST TRAUMA INSTRUMENTS LXH 3-D MACHINING INC. N/A 700706017

    Patients

    Seq Age Sex Outcome Treatment
    1