BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 3083161 · Received April 29, 2013

    Report

    Report Number
    1719045-2013-10945
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    June 13, 2012
    Report Date
    June 14, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE CONICAL EXTRACTION SCREW WAS RETURNED WITH THE TIP BROKEN OFF, ONLY APPROXIMATELY 9.1MM OF THE TIP REMAINED. PART SHOWS BURRS AT THE BREAK SITE, MARKS AND LIGHT WEAR MARKS ON THE SHAFT, INDICATING USE. BASED ON THE EVALUATION PERFORMED AND ON THE FACT THAT THE DAMAGED PORTION OF THE PRODUCT MAKES PHYSICAL DIMENSIONAL VERIFICATION OF THE TIP FEATURES IMPOSSIBLE, 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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HARDWARE REMOVAL, THE TIPS OF TWO CONICAL EXTRACTION SCREWS BROKE OFF INTO THE HEAD OF THE SCREW. ALL HARDWARE WAS REPORTEDLY REMOVED, THE BROKEN TIPS WERE RETRIEVED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183985 CONICAL EXTRACTION SCREW FSM SYNTHES MONUMENT U122855

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR