BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5410068 · Received February 4, 2016

    Report

    Report Number
    2520274-2016-10757
    Event Type
    Injury
    Date Received
    February 4, 2016
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. KRETTEK, C. ET AL (1996). UNREAMED INTRAMEDULLARY NAILING OF FEMORAL SHAFT FRACTURES: OPERATIVE TECHNIQUE AND EARLY CLINICAL EXPERIENCE WITH THE STANDARD LOCKING OPTION. INJURY, 27, 233-254. THIS REPORT IS FOR AN UNKNOWN FEMORAL NAIL/UNKNOWN QUANTITY/UNKNOWN LOT. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, KRETTEK, C. ET AL (1996). UNREAMED INTRAMEDULLARY NAILING OF FEMORAL SHAFT FRACTURES: OPERATIVE TECHNIQUE AND EARLY CLINICAL EXPERIENCE WITH THE STANDARD LOCKING OPTION. INJURY, 27, 233-254. THE AUTHORS REPORTED THE ALGORITHMS, TECHNIQUES AND PROCEDURES DEVELOPED IN THE TREATMENT OF A SERIES OF 133 FEMORAL SHAFTS WHICH WERE STABILIZED WITH THE ASSOCIATION FOR OSTEOSYNTHESIS (AO) UNREAMED FEMORAL NAIL (URFN) IN A PROSPECTIVE STUDY CONDUCTED BETWEEN JANUARY 1991 AND DECEMBER 1994. THE FIRST 57 CASES AFTER INJURY WERE REVIEWED: 42 MEN AND 15 WOMEN WITH AN AVERAGE AGE AT FOLLOW-UP OF 28 YEARS (RANGE, 16-53 YEARS). THE MEAN FOLLOW-UP WAS 17.9 MONTHS (RANGE, 5-44). RESULTS INCLUDED: NAIL BREAKAGE ATTRIBUTED TO FATIGUE FAILURE (ONE) WAS REVISED TO ANOTHER URFN WITH SUBSEQUENT UNEVENTFUL HEALING. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN FEMORAL NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68102 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention