BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANCELLOUSSCR Ø4 L30/14 TI

    MDR report key: 3173859 · Received June 17, 2013

    Report

    Report Number
    8030965-2013-03253
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    September 14, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    PRE-AM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 ADDITIONAL EVALUATION REVEALED THAT THE SCREW-LENGTH ON LABEL IS WRONG (IT READS L35 INSTEAD OF L30). THE LABEL DOES NOT CORRESPOND WITH THE SPECIFICATIONS. A DELIVERY STOP HAS BEEN STARTED. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. ALSO, AN INTERNAL CORRECTIVE ACTION DETERMINATION HAS BEEN OPENED TO ADDRESS THIS 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. THE DEVICE HISTORY RECORD REPORTS THE COMPLAINT TO BE INDETERMINATE, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. UPDATED MANUFACTURING DATE, THE INITIAL REPORTED MFR DATE AS 7/8/2011 SHOULD BE 6/30/11. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WRONG LENGTH LABEL ON SCREWS. IT SHOULD BE L30 AND IT SAYS L35. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272893 CANCELLOUSSCR Ø4 L30/14 TI HWC SYNTHES GMBH 7511375

    Patients

    Seq Age Sex Outcome Treatment
    1