BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L100 TAN

    MDR report key: 2964212 · Received February 15, 2013

    Report

    Report Number
    8030965-2013-00495
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE PFNA BLADE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. THE REVIEW REVEALED THAT THE IMPLANT WAS MANUFACTURED IN JUNE 2012 ACCORDING TO THE SPECIFICATIONS, NO ABNORMAL FINDINGS WERE IDENTIFIED. IN ADDITION THE IMPLANT WAS FOUND TO BE IN PERFECT WORKING ORDER, THE PFNA BLADE COULD BE ATTACHED TO THE INSERTER WITHOUT ANY DIFFICULTIES. UNFORTUNATELY THE EXACT CAUSE OF FAILURE COULD NOT BE DETERMINED; A POSSIBLE REASON MAY BE A WRONG ROTATING DIRECTION DURING THE ATTEMPT OF ATTACHING, LEFT HAND-THREAD. THE IMPLANT WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATES A HOSPITAL IN THE (B)(6) REPORTED: BLADE DOES NOT ATTACH TO THE INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68365 PFNA BLADE PERF L100 TAN PFNA BLADE HSB SYNTHES GMBH 7960144

    Patients

    Seq Age Sex Outcome Treatment
    1