BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø4.5 L22 SST

    MDR report key: 2928112 · Received January 24, 2013

    Report

    Report Number
    8030965-2013-00227
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    January 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INTENDED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE INVESTIGATION OF THE COMPLAINED CORTEX SCREWS SHOWS THAT THE THREAD REALLY DOES NOT CORRESPOND TO THE SPECIFICATIONS. ONE CYCLE DURING MANUFACTURING PROCESS WAS NOT CARRIED OUT AS INTENDED. THIS CONDITION UNFORTUNATELY WAS MISSED AT FINAL INSPECTION. SINCE THIS IS THE FIRST REPORTED CASE CONCERNING THE ARTICLE AND LOT NUMBER IN QUESTION AND WE WERE NOT ABLE TO DETECT OTHER DISCREPANCIES, WE CONSIDER THIS COMPLAINT TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE THREADS ON UNUSED SCREWS. TWO SCREWS, FROM A UNOPENED PACKAGE, WERE OBSERVED TO HAVE THREADS THAT ARE NOT FULLY FORMED. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34278 CORTSCR Ø4.5 L22 SST CORTICAL SCREW HWC SYNTHES GMBH 8146831

    Patients

    Seq Age Sex Outcome Treatment
    1