BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA 10 130° L240 SST

    MDR report key: 2940967 · Received February 4, 2013

    Report

    Report Number
    8030965-2013-00287
    Event Type
    Injury
    Date Received
    February 4, 2013
    Report Date
    November 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MEASURABLE DIMENSIONS WERE MEASURED AND WERE FOUND TO BE IN SPECIFICATION. WE ASSUME THAT DOMINANT DYNAMIC BENDING LOADS, DOUBLE SIDED. LED TO THE FATIGUE OF THE INVESTIGATED PFNA. OVER A PERIOD OF TIME THE IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POST OPERATIVE ACTIVITIES OF THE PATIENT DURING THE REHABILITATION IN COMBINATION WITH THE COMPLEX FRACTURE SITUATION AND AN INSTABLE FRACTURE SITUATION HAVE PLAYED A CERTAIN ROLE TOO. SEM OBSERVATIONS AND FINDINGS LED TO THE CONCLUSION THAT THE INVESTIGATED IMPLANT BROKE BECAUSE OF FATIGUE AND OVERLOAD.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT SUFFERED A FALL AND WAS IMPLANTED WITH PFNA NAIL, BOLT, AND BLADE CONSTRUCT ON (B)(6) 2012. ON AN UNKNOWN POST-OPERATIVE DATE, PATIENT COMPLAINED OF HIP PAIN. EXAMINATION REVEALED FRACTURE IN THE PFNA. PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR EXPLANT OF HARDWARE. PATIENT WAS REVISED WITH LONGER PFNA NAIL CONSTRUCT. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46221 PFNA 10 130° L240 SST PFNA NAIL HSB SYNTHES GMBH 7782912

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention