BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS/DCS-IMPACT F/ONE-STEP INSERT-TECHN F

    MDR report key: 3171582 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03298
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Date of Event
    May 26, 2011
    Report Date
    June 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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). PLACEHOLDER.

    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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION OF THE COMPLAINED DEVICE SHOWS THAT THE TIP OF THE PLASTIC PART IS BROKEN PARTIALLY. THE VISIBLE SIGNS INDICATE THAT THE PLASTIC BROKE DUE TO HIGH MECHANICAL LOADINGS. THIS DEVICE APPEARS OLD AND THIS INDICATES OFTEN USAGE UNDER HIGH CONDITIONS. THE VISIBLE SIGNS AT THE PLASTIC PART INDICATE STRONG CONTACT OF THE TIP WITH THREADED LOCKING HOLE, WHICH IS NOT NORMAL USE. IT IS NOTED, THE PLASTIC PART MUST REGULARLY CONTROLLED AND EXCHANGED. REVIEWING THE MANUFACTURING- AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE INSTRUMENT BROKE DURING THE SURGERY, ALL FRAGMENTS WERE RETRIEVED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272599 DHS/DCS-IMPACT F/ONE-STEP INSERT-TECHN F HWA SYNTHES GMBH 1709496

    Patients

    Seq Age Sex Outcome Treatment
    1