BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP MED-DIST-TIBIAL PL 3.5 LOW BEND LE 6

    MDR report key: 3070052 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-02051
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED AS TREATMENT AND NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM TI LCP LOW BEND MEDIAL DISTAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. SINGLE USE DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH LCP MEDIAL DISTAL TIBIAL PLATE AND SCREW CONSTRUCT ON AN UNSPECIFIED DATE. PATIENT WAS RETURNED TO THE OR ON AN UNSPECIFIED DATE FOR A PLANNED REMOVAL OF THE HARDWARE. DURING THE REMOVAL, IT WAS REPORTED TWO SCREW HEADS BROKE OFF DESPITE USING A TORQUE LIMITER IN ACCORDANCE TO THE SPECIFICATIONS. REPORTEDLY THE PLATE AND SCREWS WERE NOT REMOVED AND THE TWO SCREWS WERE DISCARDED OF. NO CONSEQUENCE TO THE PATIENT WAS REPORTED. IT IS UNKNOWN WHICH SCREWS ARE BROKEN. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171487 LCP MED-DIST-TIBIAL PL 3.5 LOW BEND LE 6 HRS SYNTHES USA 3739320

    Patients

    Seq Age Sex Outcome Treatment
    1