BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG LCP DHHS(TM) SIDEPLATE-SHRT BARREL 4H-STER

    MDR report key: 3012551 · Received March 20, 2013

    Report

    Report Number
    3003506883-2013-10065
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K033556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE PACKAGE WAS RECEIVED FOR A MANUFACTURING EVALUATION AND THE OUTER BOX WAS OPENED. BOTH VACUUM-SEALED PACKAGING BARRIERS WERE ALSO COMPROMISED. A DETERMINATION OF WHEN THE DAMAGE OCCURRED WAS NOT POSSIBLE. THE PLATE WAS PROCESSED THROUGH THE NORMAL OPERATIONS WITHIN STERILE PACKAGING. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    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: THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, A 130 DEGREE DHHS SIDEPLATE WAS TO BE USED. WHEN THE SEALED OUTER BOX WAS OPENED IN THE OPERATING ROOM (OR), THE INSIDE PACKAGE WAS NOTED AS SPLIT OPEN AT THE FOLD. THE PLATE WAS NOT USED IN THE PATIENT. ANOTHER PLATE WAS BROUGHT INTO THE OR AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115046 130 DEG LCP DHHS(TM) SIDEPLATE-SHRT BARREL 4H-STER KTT SYNTHES ELMIRA 4779810

    Patients

    Seq Age Sex Outcome Treatment
    1