BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3759650 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10840
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    April 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FOR TREATMENT, NOT DIAGNOSIS.ADDITIONAL NARRATIVE:¿INTERVENTIONS FOR TREATING PROXIMAL HUMERAL FRACTURES IN ADULTS (REVIEW)¿ HANDOLL, HHG, OLLIVER, BJ, AND ROLLINS, KE (2012). THE COCHRANE LIBRARY (ISSUE 12).THIS REPORT IS FOR AN UNKNOWN PHILOS SCREW/UNKNOWN LOT.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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ¿INTERVENTIONS FOR TREATING PROXIMAL HUMERAL FRACTURES IN ADULTS (REVIEW)¿ HANDOLL, HHG, OLLIVER, BJ, AND ROLLINS, KE (2012). THE COCHRANE LIBRARY (ISSUE 12). THE AUTHORS SEARCHED THE COCHRANE BONE, JOINT AND MUSCLE TRAUMA GROUP SPECIALISED REGISTER, THE COCHRANE CENTRAL REGISTER OF CONTROLLED TRIALS, MEDLINE, EMBASE AND OTHER DATABASES, AND BIBLIOGRAPHIES OF TRIAL REPORTS. THE FULL SEARCH ENDED IN JANUARY 2012. THIS ARTICLE SUMMARIZES POSTOPERATIVE FINDINGS FROM TWENTY-THREE SMALL RANDOMISED TRIALS WITH A TOTAL OF 1238 PARTICIPANTS INCLUDED. ONE RETROSPECTIVE STUDY WAS PERFORMED IN (B)(6) ((B)(6), 2010). PERIOD OF STUDY RECRUITMENT: AUGUST 2006 TO JULY 2008; 76 PATIENTS, AGED OVER 18 YEARS, WITH DISPLACED PROXIMAL HUMERAL FRACTURES WITH DISPLACEMENT > 1 CM AND ANGULATION OF FRAGMENTS > 45 DEGREES (NEER CRITERIA) EXCLUSION CRITERIA: POLY-TRAUMATISED PATIENTS, NEUROLOGIC DEFICIT OR INTRA-OPERATIVE CONVERSION TO SHOULDER ARTHROPLASTY. (PAPER NOTED THERE WERE NO OPEN OR PATHOLOGICAL FRACTURES). OF 66 PATIENTS: 48 FEMALE, 18 MALE; MEAN AGE 68 YEARS, RANGE 29 TO 92 YEARS. THE PATIENTS UNDERWENT MONOAXIAL ANGULAR STABLE PLATE FIXATION WITH PROXIMAL HUMERAL INTERNAL LOCKING SYSTEM (PHILOS) SYNTHES (B)(4). FOUR PATIENTS EXPERIENCED CUT-OUT (INTRA-ARTICULAR). IT WAS REPORTED THAT SOME OF THE PATIENTS UNDERWENT REVISION SURGERY AND EARLY HARDWARE REMOVAL (REASON FOR REVISION NOT REPORTED). IT WAS CONCLUDED THAT THERE WAS INSUFFICIENT EVIDENCE TO ESTABLISH WHAT IS THE BEST METHOD OF SURGICAL TREATMENT, EITHER IN TERMS OF THE USE OF DIFFERENT CATEGORIES OF SURGICAL INTERVENTION (SUCH AS PLATE VERSUS NAIL FIXATION, OR HEMIARTHROPLASTY VERSUS TENSION-WIRE FIXATION) OR DIFFERENT METHODS OF PERFORMING AN INTERVENTION IN THE SAME CATEGORY (SUCH AS DIFFERENT METHODS OF PLATE FIXATION). THERE IS INSUFFICIENT EVIDENCE TO SAY WHEN TO START MOBILISATION AFTER EITHER SURGICAL FIXATION OR HEMIARTHROPLASTY. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS REPORT IS FOR UNKNOWN PHILOS SCREWS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237439 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention