BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIDE/FIXED HAMMER 700 GRAMS

    MDR report key: 3021782 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-10529
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DHR WAS REVIEWED TO DETERMINE WHETHER THERE WERE ANY ISSUES WHICH COULD CAUSE OR CONTRIBUTE TO THIS COMPLAINT. THE EXAMINATION SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURING THAT WOULD CONTRIBUTE TO THIS COMPLAINT. THERE WERE TWO HANDLE PIECES RETURNED, THE BACK PORTION BEHIND THE PIN AND ONE SIDE. THE BREAK ON THAT PIECE IS ALONG THE SHAFT MIDLINE UNTIL IT INTERFACES WITH THE THE BACK PIECE AND GOES OUTWARD AT AN ANGLE. THE MISSING PIECE HAD SIMILAR PROFILE. THERE IS A LARGE DENT IN THE HANDLE JUST BELOW WHERE THE MISSING PIECE IS BROKEN AWAY. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE HEAD HAS NUMEROUS DENTS AND GOUGES INDICATING THAT THE HAMMER HAS SEEN EXTENSIVE USE. THE LOCKING COLLAR IS TIGHT AGAINST THE HEAD OF THE HAMMER. THE THREADS FOR THE COLLAR IN THE ALTERNATE LOCATION NEAR THE HANDLE ARE DAMAGED AND APPEAR TO HAVE BEEN STRUCK BY SOMETHING FLATTENING OUT THE FIRST TWO THREADS IN SPOTS. THE COLLAR WAS MOVED TO THAT LOCATION BUT COULD NOT BE THREADED ONTO IT DUE TO THE DAMAGE OF THE THREADS. THE COMPLAINT IS INVALID AS IT DOES NOT APPEAR THAT THE COMPLAINT IS A RESULT OF A DESIGN OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IM NAILING, THE SURGEON WAS HAMMERING IN THE NAIL AND THE HANDLE OF THE MALLET BROKE INTO THREE PIECES. NOTHING FELL INTO THE PATIENT. THE SURGEON USED ANOTHER MALLET AND COMPLETED THE PROCEDURE WITH NO REPORTED ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124600 SLIDE/FIXED HAMMER 700 GRAMS FZY SYNTHES GMBH 4837839

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR