BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN

    MDR report key: 2964196 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00496
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE INVESTIGATION HAS SHOWN THAT THE UPPER PART ON BOTH OF THE SHORTCUTS IS INDEED BROKEN OFF AS COMPLAINED. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS LOT IN QUESTION WAS MANUFACTURED IN JULY 2009 ACCORDING TO THE GIVEN SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND. THE BROKEN SURFACES OF THE SHORTCUTS ARE HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY AS WELL. NOTE THAT IT IS CLEARLY VISIBLE THAT THE PLATE WAS HELD IN THE IDENTICAL POSITION. NOTE THAT IT IS VITAL TO BE CUTTING PLATES WHICH ARE WITHIN THE GIVEN RANGE OF 1.5 MM, 2.8 MM. BASED ON THESE FINDINGS WE CONCLUDE THAT EXCESSIVE MECHANICAL FORCE OR POSSIBLY INAPPROPRIATE USE HAS RESULTED IN THESE BREAKAGES. THESE INSTRUMENTS WERE MANUFACTURED ACCORDING TO THE GIVEN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN THE (B)(6) REPORTED: TWO SHORTCUTS BROKE DURING CUTTING A PLATE. BOTH SHORTCUTS, SAME LOT NUMBER, BROKE DURING SAWBONE WORKSHOP, NORMAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68895 SHORTCUT F/MATMAND-PL T1.5-2.8 W/RASP IN SHORTCUT F/MATMAND HTZ SYNTHES GMBH 3200738

    Patients

    Seq Age Sex Outcome Treatment
    1