BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA 10 130 DEGREE L240 TAN

    MDR report key: 2221606 · Received August 19, 2011

    Report

    Report Number
    8030965-2011-00558
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. NOT PREVIOUSLY REPORTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. EXPIRATION DATE NOT PREVIOUSLY REPORTED. THE MEASURABLE DIMENSIONS OF THE PFNA HAVE BEEN CHECKED. THE ARTICLE CORRESPONDS WITH THE DRAWINGS AND AO/ASIF SPECIFICATIONS. THE INSPECTION OF THE RAW MATERIAL TEST CERTIFICATE AND THE MANUFACTURING DOCUMENTS SHOW NO DEVIATION ACCORDING TO MATERIAL ANALYSIS, TENSILE STRENGTH AND STRUCTURAL STABILITY AS WELL AS OF THE PRODUCTION. THE VALUE CONFORMS TO THE AO/ASIF SPECIFICATIONS AND INTERNATIONAL STANDARDS ISO 5832-11. THE INVESTIGATION OF THE COMPLAINED PFNA NAIL SHOWS A BREAK THROUGH THE DISTAL LOCKING HOLE. ON THE BASIS OF THE BREAK AND OF THE HOMOGENEOUS BREAK CHARACTERISTIC WE ASSUME THAT OVER-STRESSING OF THE IMPLANT WAS LEADING TO THE FAILURE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A HOSPITAL IN (B)(6) REPORTED: A PFNA NAIL 130 DEGREE WAS DISCOVERED BROKEN IN THE SHAFT (DISTAL LOCKING BOLT JUNCTION) AND MEDICAL/SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFNA 10 130 DEGREE L240 TAN PFNA 10 130 DEGREE HSB SYNTHES GMBH 2678852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DISTAL LOCKING BOLT