BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    MDR report key: 2943660 · Received February 5, 2013

    Report

    Report Number
    2530088-2013-00106
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. CORRECTED DEVICE RECEIVED DATE FROM (B)(4) 2013. DEVICE WAS RECEIVED FOR EVALUATION ON (B)(4) 2013.

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DHR WAS REVIEWED AND MRR# (B)(4) WAS FOUND ON P/N (B)(4) LOT #5002819 FOR NO OP.# OR REV# ON THE SUPPLIER CERTIFICATE OF CONFORMANCE. THE SUPPLIER PROVIDED THE MISSING INFORMATION ON REWORK AND THE PARTS WERE ACCEPTED. MRR #(B)(4) WAS FOUND ON P/N (B)(4) LOT #5033352 FOR MACHINE LINES ON THE PARTS. THE PARTS WERE REWORKED AND FAILED. MRR #(B)(4) WAS FOUND FOR MACHINE LINES STILL ON PARTS AFTER REWORK. THE PARTS WERE REWORKED AND PASSED. THESE TWO NONCONFORMANCES ARE NOT RELEVANT TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    THE PD EVENT EVALUATION DETERMINED THAT THE DESIGN SPECIFIES APPROVED MATERIAL TYPES AND FINISHING SPECIFICATIONS FOR THE SCREWDRIVERS. THE DESCRIPTION NOTED IN THE COMPLAINT WAS NOT SEEN ON THE RETURNED PRODUCT, AND COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    THE O.R. DIRECTOR REPORTED FIVE (5) SCREWDRIVERS THAT WERE PEEL PACKED INDIVIDUALLY WHILE GOING THROUGH STERILIZATION, LEFT A GREASY SUBSTANCE ON THE INSIDE OF THE PACKAGE WHEN OPENED UP. THE O.R. STAFF DOES NOT FEEL THEY ARE STERILE DUE TO THE GREASY SUBSTANCE AND FEEL THEY COULD BE A POTENTIAL PROBLEM. THE SALES CONSULTANT BELIEVES THESE WERE NOT INVOLVED IN A SURGERY AND THAT THEY ARE PROACTIVELY BEING REPORTED BY THE HOSPITAL. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48193 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER HEXAGONAL SCREWDRIVER HXX SYNTHES BRANDYWINE 5136441

    Patients

    Seq Age Sex Outcome Treatment
    1