BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL

    MDR report key: 3192955 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-03750
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    December 29, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KIH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. ADDITIONAL PRODUCT CODE: FZX. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. NO MANUFACTURING DEFICIENCIES WERE NOTED. THE PRESENT NEEDLE WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS, NO ABNORMAL FINDINGS WERE IDENTIFIED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES AND AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. BASED ON THE APPEARANCE OF THE TIP WE ASSUME THAT THE SYSTEM WAS OVERSTRAINED DURING USE. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP IS BENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294467 VERTEBROPLASTYNEEDLE KIT 12-GAUGE CANNUL KIH SYNTHES GMBH AIW947

    Patients

    Seq Age Sex Outcome Treatment
    1