BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H+PIECE F/PIEZOELECTRIC SYSTEM

    MDR report key: 3174185 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03543
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    November 7, 2011
    Report Date
    November 11, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSZ
    PMA / PMN Number
    K043310
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. THE DHR REVIEW WAS NOT POSSIBLE AS THE LOT NUMBER PROVIDED IS UNKNOWN AT THE MANUFACTURING SITE. THIS DEVICE IS DISTRIBUTED BY SYNTHES ONLY AND THE LEGAL MANUFACTURER OF THIS DEVICE IS (B)(4). FURTHER INVESTIGATION CANNOT BE PERFORMED.

    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.(B)(4)

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE CADAVER LAB THE HAND PIECE BECAME HOT. THE SURGEON WAS TRYING THE HAND PIECE ON A PIG BONE WITH SETTINGS AT D1-5 WITHOUT ANY CONTACT OF THE PIEZO-TIP TO THE BONE. THE HAND PIECE BECAME HOTTER AND HOTTER, ARRIVING AT 49 DEGREES CELSIUS. THE IRRIGATION WAS ON 80ML. THIS HAND PIECE IS A DEMO ONE AND IS INCLUDED IN A CADAVER SET. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272978 H+PIECE F/PIEZOELECTRIC SYSTEM HSZ SYNTHES (USA) 203965.013

    Patients

    Seq Age Sex Outcome Treatment
    1