BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM HEX ADJ SCRWDRVR BLADE W/SPADE POINT HXC(REPLACEMENT)

    MDR report key: 2838566 · Received November 19, 2012

    Report

    Report Number
    1719045-2012-01166
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR LOT U153475 REVEALED THE STERNAL SCREWDRIVER WAS MANUFACTURED BY ORCHID UNIQUE. PO 1364637, DATED (B)(4) 2012, FOR 14 PARTS, WAS INSPECTED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET AND THE PRODUCT CONFORMED TO ALL REQUIREMENTS.

    Description of Event or Problem · 1

    A (B)(4) EVENT REPORT, (B)(4), WAS RECEIVED BY SYNTHES ON (B)(6) 2012: IT WAS REPORTED BY THE RISK MANAGER OF THE FACILITY: DURING CLOSURE OF A CABG THE TIP OF THE SCREWDRIVER BROKE OFF AND THE TIP WAS NOT FOUND. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM HEX ADJ SCRWDRVR BLADE W/SPADE POINT HXC(REPLACEMENT) HEX ADJ SCRWDRVR BLADE HWC SYNTHES MONUMENT U153475

    Patients

    Seq Age Sex Outcome Treatment
    1