BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AWL Ø2 ANGL

    MDR report key: 2899795 · Received January 7, 2013

    Report

    Report Number
    8030965-2013-00040
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: FZH, HWJ. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PERFORMED INVESTIGATION HAS SHOWN THAT TIP OF AWL IS BROKEN. THE FRACTURE SURFACE HAS A HOMOGENEOUS STRUCTURE, WHICH INDICATES A PERFECT MATERIAL QUALITY. BASED ON THESE FINDINGS, WE BELIEVE THAT EXCESSIVE MECHANICAL STRESS LED TO THE DAMAGE OF THE TIPS. THE 510K #: SHOULD HAVE BEEN K112068.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: AWLS ARE BROKEN OR BENT. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6145 AWL Ø2 ANGL AWL OVE SYNTHES GMBH 7742645

    Patients

    Seq Age Sex Outcome Treatment
    1