BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5 MM LACTO ADJ SD TAP

    MDR report key: 5444546 · Received February 18, 2016

    Report

    Report Number
    0001032347-2016-00100
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    May 27, 2014
    Report Date
    February 16, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWX
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PART OF A RETROSPECTIVE REVIEW, ALTHOUGH NO ADVERSE EVENT WAS REPORTED, THIS DEVICE HAS HAD A SIMILAR MALFUNCTION THAT HAS CAUSED OR CONTRIBUTED TO SERIOUS INJURY. THE IFU STATES "THE PATIENT IS TO BE WARNED BY HIS PHYSICIAN OF ALL SURGICAL RISKS, INCLUDING THE RISK OF FRACTURE OR BREAKAGE. INSTRUMENTS ARE AVAILABLE TO AID IN THE ACCURATE IMPLANTATION OF INTERNAL FIXATION DEVICES. INTRAOPERATIVE FRACTURE OR BREAKAGE OF SURGICAL INSTRUMENTS IN GENERAL HAS BEEN REPORTED. INSTRUMENTS WHICH HAVE EXPERIENCED EXTENSIVE USE OR EXCESSIVE FORCE ARE SUSCEPTIBLE TO FRACTURE. SURGICAL INSTRUMENTS SHOULD ONLY BE USED FOR THEIR INTENDED PURPOSE." THE TAPS WERE VISUALLY EVALUATED WITH A DIGITAL MICROSCOPE AND FOUND TO BE BROKEN ON THE THREADED PORTION ON THE TAP. THERE IS NO DISCOLORATION ON THE TAPS. THE FRACTURE IS THROUGH THE MINOR DIAMETER ABOUT HALF WAY INTO THE THREADED PORTION OF THE TAP AND IS CONSISTENT WITH AN OVER TORQUED TAP. THE ADJUSTABLE TAP STOP (915-1595-02) WAS NOT RETURNED FOR EVALUATION. USING A 50X COMPARATOR, THE MINOR AND MAJOR DIAMETER WERE INSPECTED AND FOUND TO BE WITHIN TOLERANCE. THERE WERE NO INDICATIONS OF MANUFACTURING DEFECTS. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT ISSUE IS EXCESSIVE FORCE APPLIED TO THE TAPS. REPORT TWO OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2016-00099.

    Description of Event or Problem · 1

    IT IS REPORTED TWO TAPS BROKE DURING USE. THE CUSTOMER STATED THIS WAS THE FIRST USE OF THE DEVICES. NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102288 1.5 MM LACTO ADJ SD TAP LACTOSORB TAP HWX BIOMET MICROFIXATION N/A 887820

    Patients

    Seq Age Sex Outcome Treatment
    1