BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APP CORTICAL SCREW

    MDR report key: 4290817 · Received November 20, 2014

    Report

    Report Number
    8043862-2014-00016
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    September 10, 2014
    Report Date
    November 20, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HWC
    PMA / PMN Number
    K072411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER CHECKING THE RETURNED PIECES, IT IS MOST LIKELY THAT FRAGMENTS REMAINED IN THE PATIENT. BASED ON THE PROVIDED REPORT OF THE DISTRIBUTOR AAP ASSUMES THAT THE SURGEON DID NOT USE THE TAP AFTER PRE-DRILLING. THE AFFECTED SCREWS ARE NOT SELF TAPPING. THEREFORE USING THE TAP AFTER DRILLING IS MANDATORY. IF THE SURGEON DID NOT USE THE TAP, THE NECESSARY TORQUE FOR INSERTION OF THE SCREWS IS TOO HIGH FOR THE SCREWS. A FAILURE OF THE SCREWS IS UNDER THESE CIRCUMSTANCES A COMMON ISSUE. THEREFORE AAP WILL NOT INITIATE FURTHER EXAMINATIONS.

    Description of Event or Problem · 1

    THREE CORTICAL SCREWS BROKE WHILE SURGEON WAS DRIVING SCREWS INTO BONE. BONE WAS PRE-DRILLED WITH CORRECT DRILL BIT. SURGEON DID NOT OVER-TORQUE. SURGEON USED CORRECT MINI FRAG SCREWDRIVER. SCREWS: SK 1500-14-2 LOTCODE I030 ONE SCREW. SK 2001-12-2 LOTCODE I060 TWO SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755294 APP CORTICAL SCREW HWC AAP IMPLANTATE AG SK-2001-12-2 I060

    Patients

    Seq Age Sex Outcome Treatment
    1