BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM

    MDR report key: 3053509 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10528
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    May 2, 2012
    Report Date
    May 7, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    DZL
    PMA / PMN Number
    K983485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE SHAFT OF THE SCREW REMAINS IN IMPLANTED IN THE PATIENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURING EVALUATION, VISUAL INSPECTION REPORT STATED THAT THE SCREW IS BROKEN AT THE SHAFT JUST ABOVE THE THREADS. ONLY THE HEAD END OF THE SCREW WAS RETURNED FOR EVALUATION. THE HEAD IS DAMAGED AROUND THE CROSS SLOT AND THERE ARE NICKS IN THE NECK. THE VISUAL EXAMINATION IS CONSISTENT WITH PRODUCT COMPLAINT. THE HEAD PROFILE, THREAD MAJOR DIAMETER AND HEAD TO THREAD DISTANCE COULD NOT BE MEASURED BECAUSE THE THREADED PORTION OF SCREW WAS NOT AVAILABLE FOR REVIEW. THE HEAD PROFILE COULD NOT BE MEASURED DUE TO DAMAGE. SINCE ALL THE RELEVANT FEATURES COULD NOT BE CHECKED AND NO LOT NUMBER WAS PROVIDED THIS COMPLAINT IS 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. ORIGINAL AWARENESS DATE IS (B)(6) 2012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MULTIPLE MIDFACE FRACTURE PROCEDURE, THE SURGEON WAS INSERTING THE SCREW INTO THE ZYGOMA/ORBITAL RIM AND THE SCREW (400.456E) BROKE AT THE FIRST THREAD. THE BROKEN FRAGMENT WAS RETRIEVED. THE SCREW SHAFT REMAINS IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEMS. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154775 1.3MM TI CRTX SCREW SLF-DRLG W/PLUSDRIVE(TM) RECESS 6MM DZL SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1