BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES

    MDR report key: 3099659 · Received March 20, 2013

    Report

    Report Number
    MW5030074
    Event Type
    Other
    Date Received
    March 20, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SYNTHES
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH A DISPLACED FRACTURE OF THE RIGHT MEDIAL CONDYLE OF THE HUMERUS. DURING OPEN REDUCTION AND INTERNAL FIXATION REPAIR OF THE FRACTURE, THE TAP SHEARED OFF. SURGEON DETERMINED THE TAP PIECE WAS TO REMAIN WHERE IT LODGED; REMOVAL WOULD INCUR GREATER RISK. THE SURGEON WAS ABLE TO GET THE SCREW ACROSS IN A SLIGHTLY DIFFERENT TRAJECTORY THAN WHERE THE TAP WAS AND THE PROCEDURE RESULTED IN EXCELLENT FIXATION. REFERENCE MFR REPORT# 2520274-2013-1963.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116583 SYNTHES SYNTHES TAP HWX SYNTHES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other SYNTHES SCREWS: CATALOG NUMBERS: 215.065 (ONE),| 217.065 (ONE), 217.080 (ONE)