BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE ATTACHMENT FOR PEN DRIVE

    MDR report key: 3006788 · Received March 15, 2013

    Report

    Report Number
    8030965-2013-00910
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWE
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRO CODES: DZI, ERL, HBE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED PROBLEM WAS CONFIRMED. THIS CONDITION WAS LIKELY DUE TO NORMAL COMPONENT WEAR FROM USE OVER TIME.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE HAS NOT BEEN RETURNED AT THIS TIME.

    Description of Event or Problem · 1

    THIS REPORT IS #1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FACILITY REPORTS DURING A METACARPAL FRACTURE PROCEDURE, THE K WIRE ATTACHMENT WOULD NOT SECURE THE WIRE. SURGEON USED ANOTHER ATTACHMENT TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEM, NO HARM TO PATIENT. NO DELAY IN PROCEDURE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108805 K-WIRE ATTACHMENT FOR PEN DRIVE HWE SYNTHES GMBH 1697854

    Patients

    Seq Age Sex Outcome Treatment
    1