BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2013-11098

    MDR report key: 3061822 · Received April 16, 2013

    Report

    Report Number
    2520274-2013-11098
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    May 17, 2012
    Report Date
    May 17, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. ADDITIONAL INFORMATION: THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR 1 UNKNOWN SCREW. (B)(6). 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.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL OSTEOTOMY, THE SELF-DRILLING TIP OF THE SCREW BROKE OFF IN THE TIBIA. THE SCREW WAS REMOVED, LEAVING THE BROKEN TIP IN THE TIBIA OF THE PATIENT. THE SURGEON EXAMINED THE SCREW AND THEN REINSERTED THE SCREW INTO THE TIBIA. THE SURGEON INSERTED 2 MORE SCREWS AND COMPLETED THE SURGERY WITHOUT INCIDENT. NO ADVERSE EFFECT ON THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163836 HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR