BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER T8

    MDR report key: 3070249 · Received April 22, 2013

    Report

    Report Number
    3003787298-2013-10089
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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. ORIGINAL AWARENESS DATE IS 07/27/2011. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION WHICH SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SYNTHES, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 MANUFACTURING EVALUATION REVEALED THE END OF THE STARDRIVE TIP WAS TWISTED WHICH IS NOT A RESULT OF THE MANUFACTURING PROCESS. ALL FEATURES RELATED TO THIS COMPLAINT THAT COULD BE VERIFIED DURING THIS EVALUATION MEET SPECIFICATIONS, BUT ALL FEATURES RELATED TO THIS COMPLAINT COULD NOT BE VERIFIED DUE TO DAMAGE, THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. THE VISUAL INSPECTION DONE DURING THE PRODUCT EVALUATION REVEALED THE SCREWDRIVER SHOWED TYPICAL SIGNS OF WEAR, AND THE TIP WAS TWISTED AROUND AS DESCRIBED IN THE COMPLAINT. SINCE IT IS UNKNOWN HOW MANY TIMES THE SCREWDRIVER HAS BEEN USED, OR IF IT HAD BEEN SUBJECTED TO ANY EXTRANEOUS CIRCUMSTANCES, THIS COMPLAINT IS DEEMED INDETERMINATE.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON WAS USING A SCREWDRIVER TO INSERT THE SCREWS AND THE SCREWDRIVER BROKE AT THE TIP. NO PIECES OF THE SCREWDRIVER WERE LEFT INSIDE THE PATIENT. THE SURGEON USED A DIFFERENT SCREWDRIVER TO COMPLETE THE PROCEDURE. NO EXTRA TIME WAS ADDED ONTO THE PROCEDURE. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171348 STARDRIVE SCREWDRIVER T8 HXX SYNTHES JENNERSVILLE 6552246

    Patients

    Seq Age Sex Outcome Treatment
    1