BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM/3.5MM VA-LCP OLECRANON PL 6H/LT/142MM

    MDR report key: 3072445 · Received April 23, 2013

    Report

    Report Number
    3003506883-2013-10139
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 13, 2012
    Report Date
    July 13, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K120070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. 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. ADDITIONAL INFORMATION: THE DEVICE HISTORY RECORD SHOWED THE MANUFACTURE DATE FOR LOT 6963745 WAS 6-18-2012. REPORTEDLY, THE PACKAGE LABEL INDICATED THIS LOT NUMBER. MANUFACTURE DATE FOR LOT 6970961 WAS STARTED ON 6-20-2012 AND RELEASED TO WAREHOUSE ON 6-28-2012. REPORTEDLY, THE PRODUCT WAS LASER ETCHED WITH THIS LOT NUMBER. THE LOT 6970961 PRODUCT REPORTEDLY PACKAGED AND LABELED AS LOT 6963745 WAS NOT INITIATED UNTIL 2 DAYS AFTER PRODUCT WAS RELEASED TO THE DISTRIBUTION WAREHOUSE. THE NEWER LOT NUMBER DID NOT EXIST IN ANY SYSTEMS AT THAT POINT IN TIME, SO COULD NOT HAVE BEEN USED FOR THE PACKAGE LABEL. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS HE WAS PUTTING HIS SALES SAMPLE SET TOGETHER AND THAT THE PART AND LOT NUMBERS ON THE PACKAGING DID NOT MATCH THE PART AND LOT NUMBERS ON THE PRODUCT. PACKAGE SHOWS PART 02.107.306 LOT 6963745. PRODUCT SHOWS PART 02.117.901 LOT 6970961. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175056 2.7MM/3.5MM VA-LCP OLECRANON PL 6H/LT/142MM HRS SYNTHES ELMIRA 6963745

    Patients

    Seq Age Sex Outcome Treatment
    1