BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3982172 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12575
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    March 29, 2010
    Report Date
    July 9, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TITANIUM ENDOMEDULLARY NAIL. 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. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, LIU, H. ET AL. (2009, (B)(6)). COMPARISON OF PLATES VERSUS INTRAMEDULLARY NAILS FOR FIXATION OF DISPLACED MIDSHAFT CLAVICULAR FRACTURES. THE JOURNAL OF TRAUMA INJURY, INFECTION, AND CRITICAL CARE, 69, E82-E87. THE AUTHORS CONDUCTED A RETROSPECTIVE CASE SERIES TO COMPARE TWO TREATMENTS, OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH SYNTHES DEVICES, PLATE AND SCREWS, VERSUS ELASTIC STABLE INTRAMEDULLARY NAILING (ESIN) USING SYNTHES DEVICES, TITANIUM ENDOMEDULLARY NAILS (TEN) OF PATIENTS WITH DISPLACED MIDCLAVICULAR FRACTURES. THE STUDY SAMPLE CONSISTED OF 59 PLATE FIXED PATIENTS (29 MEN, 30 WOMEN), AVERAGE AGE 31.7 YEARS (RANGE, 17 TO 58 YEARS) AND 51 NAIL FIXED PATIENTS (32 MEN, 19 WOMEN), AVERAGE AGE 33.6 YEARS (RANGE, 16 TO 65 YEARS) WHO RECEIVED EITHER PLATES OR NAILS BETWEEN (B)(6) 2006 AND (B)(6) 2007. THE MEAN FOLLOW-UP WAS 17.7 MONTHS (RANGE, 12-27 MONTHS). OUTCOMES INCLUDED OPERATIVE AND POSTOPERATIVE MEASUREMENTS AND PATIENT PERFORMANCE. IN THE PLATE GROUP, THE AUTHORS REPORTED SIX NONUNION, TWO MALUNION REQUIRING FURTHER UNSPECIFIED TREATMENT, SIX WOUND INFECTION/DEHISCENCE, 12 HARDWARE IRRITATIONS REQUIRING REMOVAL AND FIVE EARLY MECHANICAL FAILURE. IN THE NAIL GROUP, THE AUTHORS REPORTED FIVE NONUNION, FOUR MALUNION REQUIRING FURTHER UNSPECIFIED TREATMENT, THREE WOUND INFECTION/DEHISCENCE, FOUR HARDWARE IRRITATION REQUIRING REMOVAL AND FOUR EARLY MECHANICAL FAILURE. THIS IS A REPORTABLE MALFUNCTION REPORT FOR FOUR EARLY MECHANICAL FAILURES. THIS REPORT IS FOR AN UNKNOWN TITANIUM ENDOMEDULLARY NAIL. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457183 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1