BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CRUCIFORM SCREWDRIVER

    MDR report key: 3298146 · Received August 20, 2013

    Report

    Report Number
    2530088-2013-01125
    Event Type
    Malfunction
    Date Received
    August 20, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 23, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE ASSEMBLY DHR WAS REVIEWED AND DHR #4173707 FOR P/N 314.462.05 WAS NOT ABLE TO BE LOCATED IN DOCUSPHERE. THE LOT NUMBER 4173707 IS CORRECT IN JDE FOR P/N 314.462.05. ALL OTHER DHRS WERE REVIEWED AND NO ISSUES WERE FOUND DURING MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATERIAL AND HARNESS MET SPECIFICATIONS. ONE CANNULATED CRUCIFORM SCREWDRIVER FOR 3.0MM CANN SCREW WAS RETURNED. THE BLADES ON THE TIP OF THE RETURNED INSTRUMENT ARE BROKEN OFF AND WERE NOT RETURNED. FEATURES L6, L7 AND G1 ARE NOT ABLE TO BE CHECKED BECAUSE THE BLADES ARE MISSING AND WERE NOT RETURNED. A COMPLETE EVALUATION CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS. IT WAS REPORTED THAT A CANNULATED CRUCIFORM SCREWDRIVER BROKE DURING SCREW INSERTION. THERE WAS REPORTEDLY NO HARM TO THE PATIENT OR OTHERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402806 CANNULATED CRUCIFORM SCREWDRIVER HXX SYNTHES BRANDYWINE 4301713

    Patients

    Seq Age Sex Outcome Treatment
    1