BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 10MM

    MDR report key: 3077678 · Received April 25, 2013

    Report

    Report Number
    1719045-2013-00440
    Event Type
    Malfunction
    Date Received
    April 25, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K981275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. TWO SCREWS, P/N 400.809.96 AND 400.810.96, WERE RETURNED FOR EVALUATION. BOTH SCREWS ARE BROKEN JUST BELOW THE HEAD. ONE OF THE SCREWS HAD A SMALL PORTION OF THREADS REMAINING. THE DIMENSIONAL ANALYSIS FOR THIS MANUFACTURING EVALUATION WAS PERFORMED ON THE SCREW WITH THREADS REMAINING. THE THREAD PROFILE, THREAD MAJOR DIAMETER AND THREAD MINOR DIAMETER WERE CHECKED ON SECTION OF REMAINING THREAD AND NO ISSUES WERE FOUND. SINCE NO ISSUES WERE FOUND ON THE DIMENSIONS THAT COULD BE CHECKED AND NOT LOT NUMBER WAS PROVIDED THIS COMPLAINT IS INDETERMINATE FROM A MANUFACTURING STANDPOINT. NOT

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BOTH SCREWS ARE COVERED UNDER RISK ANALYSIS SE 241848. THE RISK ASSESSMENT LISTS THE SEVERITY OF THIS FAILURE AS A 3; HOWEVER, BASED ON THE SLIGHT ELONGATION OF OR TIME, AS DESCRIBED BY THE SALES CONSULTANT, THE SEVERITY FOR THIS FAILURE IS ACTUALLY A 2. THE PROBABILITY OF THIS FAILURE OF THE 9MM SCREW IS A 1, 3 COMPLAINTS OF THIS TYPE IN (B)(4) SALES, AND THE PROBABILITY OF THIS FAILURE THE 10MM SCREW IS A 1, 5 COMPLAINTS OF THIS TYPE IN (B)(4) SALES. THE EXACT CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. FROM SYNTHES MONUMENT TO SYNTHES USA: LOT NUMBER IS UNKNOWN. RETRACT SYNTHES MONUMENT ADDRESS: LOT NUMBER IS UNKNOWN. (B)(4). NO DHR WAS PERFORMED: LOT NUMBER UNKNOWN.

    Description of Event or Problem · 1

    PATIENT HAD OPEN REDUCTION INTERNAL FIXATION - ORIF OF THREE METACARPAL FRACTURES USING 1.5MM MODULES FROM MODULAR HAND SET - COMBINATION OF PLATES AND SCREWS - ON FEBRUARY 6, 2013. TWO WERE REPAIRED WITHOUT INCIDENT. DURING THE LAST METACARPAL REPAIR THE SURGEON EXPERIENCED TWO BROKEN SCREWS - PART NUMBERS 400.809.96 AND 400.810.96. THE SURGEON WAS NOT ABLE TO REMOVE THE SHAFT OF SCREW IN EITHER CASE. THE HEADS OF THE SCREWS ARE AVAILABLE FOR RETURN. THE BONE HAD BEEN DRILLED WITH THE APPROPRIATE 1.1MM DRILL BIT. THE BONE APPEARED TO BE VERY HARD AS SHE HAD DIFFICULTY DRIVING IN THE SCREWS. SURGERY TIME WAS NOT EXTENDED. THIS IS REPORT #2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179467 1.5MM TI CORTEX SCREW SELF-TAPPING 10MM HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR