BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 500 GRAMS

    MDR report key: 3043476 · Received April 9, 2013

    Report

    Report Number
    8030965-2013-10769
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    April 25, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE PARTS WERE SENT FROM THE ACCOUNT TO MONUMENT FOR DECONTAMINATION AND THERE IS NO EVIDENCE OF THE BROWNISH SUBSTANCE-RESIDUE LEFT ON THE PARTS. WHEN THE COMPLAINT WAS TAKEN, A REQUEST WAS MADE TO THE SALES CONSULTANT TO HAVE THE PARTS RETURNED DIRECTLY TO THE CHU SO THAT THE SUBSTANCE COULD BE EVALUATED AND THERE WOULD BE NO POTENTIAL FOR THE BROWNISH SUBSTANCE TO BE REMOVED DURING THE DECONTAMINATION PROCESS. THE PARTS WERE RETURNED THROUGH MONUMENT WHERE THEY WERE DECONTAMINATED AND AS A RESULT, THERE WAS NO SUBSTANCE-RESIDUE ON THE RETURNED PARTS. THEREFORE NO EVALUATION IS POSSIBLE AND NO DETERMINATION CAN BE MADE ON THE COMPLAINT. THE HAMMERS ALL SHOW SIGNS OF CONSIDERABLE USE WITH NUMEROUS DENTS AND ROLLED EDGES ON THE HAMMER FACES. THREE OF THE RETURNED PARTS WERE MADE IN 2003, 4 WERE MADE IN 2006, 1 IN 2007, 1 IN 2009 AND THE FINAL ONE IS UNKNOWN SINCE THERE IS NO PART OR LOT NUMBER ON THE RETURNED INSTRUMENT. THE CONDITION COULD NOT BE CONFIRMED OR REPLICATED BECAUSE THE PARTS WERE CLEANED AND DECONTAMINATED IN MONUMENT PRIOR TO BEING SENT TO THE CHU PER THE STANDARD PROCESS. THE SUBSTANCE IS NO LONGER PRESENT AND THEREFORE THE SOURCE AND COMPOSITION CANNOT BE DETERMINED AND THE COMPLAINT IS INDETERMINATE.

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THERE IS A BROWNISH SUBSTANCE-RESIDUE THAT IS SECRETING OUT OF THE HANDLE OF THE HAMMER 500 GRAMS (399.42) AND NOTICED ON THE BOTTOM OF THE PAN AFTER STERILIZATION. HOSPITAL HAS PULLED ALL OF THE HAMMERS OFF THE SHELF AND IS DEEMED UNSTERILE BECAUSE OF THE LEACHING RESIDUE. NO PATIENT INVOLVEMENT. THIS IS 5 OF 10 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147450 HAMMER 500 GRAMS FZY SYNTHES GMBH A7PA28

    Patients

    Seq Age Sex Outcome Treatment
    1