BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L12 TAN

    MDR report key: 2883691 · Received December 21, 2012

    Report

    Report Number
    1719045-2012-01425
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DYX
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION IS ONGOING; NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DHR WAS REVIEWED WITH NO COMPLAINT RELATED ANOMALIES NOTED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ONE SCREW WAS RECEIVED WITH THE TASK ASSOCIATED WITH THIS COMPLAINT. THIS SCREW IS PACKAGED IN A SYNTHES (B)(4) MARKET TYPE BAG. THE PACKAGE WAS PROPERLY SEALED WITH NO TEARS OR OPENINGS OF ANY KIND. IT IS IDENTIFIED AS PART NUMBER 04.210.112, LOT NUMBER 6818859. THE PART WAS FIRST EXAMINED UNDER 10 X MAGNIFICATIONS THROUGH THE SEALED BAG. CHIP WRAP WAS FOUND IN THE NECK AREA OF THE SCREW. THE PACKAGE WAS THEN OPENED TO FURTHER EXAMINE THE SAMPLE. NO OTHER BURRS/ANOMALIES WERE FOUND. THE CHIP WRAP CAN BE SEEN WITH THE NAKED EYE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS. IT WAS REPORTED THAT THERE WERE VISIBLE CHIPS ON THE SCREW HEAD. THE SCREW WAS NOTED TO BE IN AN UNOPENED PACKAGE TAKEN FROM STOCK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA LOCKSCR Ø2.4 SELF-TAP L12 TAN VA LOCKSCR Ø2.4 SELF-TAP L12 TAN DYX SYNTHES MONUMENT 6818859

    Patients

    Seq Age Sex Outcome Treatment
    1