BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT R SHA

    MDR report key: 3192559 · Received June 27, 2013

    Report

    Report Number
    3003506883-2013-00276
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    October 15, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K001978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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)(6). A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE INVESTIGATION HAS SHOWN THAT INDEED ALL RETURNED ARTICLES SHOW SOME DISCOLORATION/MARKS ON THE SURFACE. BASED ON THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    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 PLATES HAVE BEEN IN THE WASHING MACHINES SEVERAL TIMES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF LCP PROXIMAL TIBIA PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED. THE COMPLAINT DETERMINED TO BE INVALID BASED ON THE DHR REVIEW ONLY. NO DEVICE WAS RETURNED FOR DIMENSIONAL INSPECTION.

    Description of Event or Problem · 1

    THE PLATES HAVE BEEN IN THE WASHING MACHINES SEVERAL TIMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE BLACK DOTS FOUND ON THE INSTRUMENT. ON THE PLATES THERE WERE PROXIMAL SMALL BLACK DOTS, OR MARKS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292257 LCP PROXIMAL TIBIAL PL 4.5/5.0 LAT R SHA HRS SYNTHES ELMIRA 6534250

    Patients

    Seq Age Sex Outcome Treatment
    1