BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K-WIRE 1.25 L150 SST 10U

    MDR report key: 3083402 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10966
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 3, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LRN
    PMA / PMN Number
    EXEMPT
    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. 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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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. THE MANUFACTURING EVALUATION SHOWED THE PARTS (QTY X 10) WERE RECEIVED IN A PLASTIC POUCH WITH THE LABEL ATTACHED TO IT. THE PARTS DID NOT SEEM TO HAVE BEEN USED. THE PARTS WERE "GOLD" IN COLOR AND HAD A ROTARY LASER ETCH RING, LOCATED APPROXIMATELY 40.00MM FROM THE TIP OF THE PARTS. AFTER REVIEWING THE PARTS AND THE LABEL, IT WAS DETERMINED THAT THESE PARTS WERE NOT MANUFACTURED IN ELMIRA. PART # 292.120.10 OR 292.120 DO NOT EXIST IN ELMIRA. PART # 292.12 DOES EXIST IN ELMIRA, BUT IT IS NOT "GOLD" IN COLOR AND DOES NOT HAVE A ROTARY LASER ETCH RING, LOCATED APPROXIMATELY 40.00MM FROM THE TIP OF THE PART. AFTER FURTHER INVESTIGATION, A TABULATED SYNTHES-EU DRAWING # SE_250659 REV. B, WAS LOCATED IN THE AGILE SYSTEM AND IT DOES LIST PART # 292.120. LASTLY, THE LABEL LISTS (B)(4) SWITZERLAND AS THE MANUFACTURER. GIVEN THE INFORMATION ABOVE, THIS COMPLAINT IS FOUND TO BE INDETERMINATE. ORIGINAL AWARENESS DATE IS (B)(4) 2012. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELING WAS INCORRECT. THE DEVICE WAS LABELED AS STEEL INSTEAD OF TITANIUM MATERIAL. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185062 K-WIRE 1.25 L150 SST 10U LRN SYNTHES MONUMENT 3278171

    Patients

    Seq Age Sex Outcome Treatment
    1