BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/12MM

    MDR report key: 3070910 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-11036
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 22, 2011
    Report Date
    November 22, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DATE OF EVENT REPORTED INCORRECTLY, DATE IS UNKNOWN. 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION IN THE COMPLAINT FILE INDICATES THAT THE DEVICE IN QUESTION WAS RETURNED TO SYNTHES; HOWEVER, THE MDR REPORTABILITY STATUS AT THE TIME OF THE DEVICE RETURN WAS NOT-REPORTABLE. NO EVALUATION OF THE PRODUCT WAS REQUIRED FOR MDR NON-REPORTABLE COMPLAINTS PER THE COMPLAINT INVESTIGATION PROCEDURE AT THE TIME OF THE PRODUCT RECEIPT AND COMPLAINT INVESTIGATION. THIS FILE WAS REVIEWED UNDER PROTOCOL 2013-3000 FOR MDR REMEDIATION AND THE MDR REPORTABILITY DECISION WAS REVISED TO MDR REPORTABLE. THE PRODUCT IS NO LONGER AVAILABLE FOR ANALYSIS. INITIAL REPORT INDICATED PRODUCT WAS NOT RETURNED. ORIGINAL AWARENESS DATE IS 11/22/2011.

    Description of Event or Problem · 1

    HOSPITAL CALLED CONSULTANT AND REPORTED: PATIENT STATUS POST PREVIOUS STERNOTOMY PRESENTED TO OPERATING ROOM WITH NON-UNION AND INFECTION. POOR TISSUE QUALITY WAS NOTED AND PATIENT WAS IMPLANTED WITH THREE SYNTHES STERNAL LOCKING PLATES AND TWENTY SEVEN SCREWS. ON (B)(6) 2011. FIVE DAYS POST OPERATIVELY PATIENT WAS RETURNED TO OPERATING ROOM DUE TO BLEEDING ISSUES WITH HARDWARE, REMOVED ON (B)(6) 2011. SYNTHES CONSTRUCT WAS NOTED AS INTACT AND SURGEON NOTED HE DID NOT BELIEVE THE BLEEDING IS ATTRIBUTABLE TO SYNTHES PRODUCT, NOTHING WAS WRONG WITH THE HARDWARE. THIS IS 3 OF 3 REPORTS FOR THIS EVENT

    Description of Event or Problem · 1

    THIS IS 3 OF 3 REPORTS FOR THIS (B)(4). THIS REPORT IS FOR 27 STERNAL LOCKING SCREWS LOT NUMBER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171755 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/12MM HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention