BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 3912823 · Received July 3, 2014

    Report

    Report Number
    9612488-2014-10259
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE 510K#: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DR USED SUN FEMER NAIL TO TREAT SHAFT FEMER FRACTURE BUT ON A FOLLOW UP VISIT, DR DISCOVERED THAT THE NAIL WAS BEND FROM ITS SHAFT REGION. DEVICE HAS NOT BEEN EXPLANTED. REPORT OF DEFORMITY, ANGULATION AT FRACTURE SITE, NOT YET UNITED. PATIENT IS CURRENTLY ON REST WAITING FOR UNION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391148 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 8391794

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR