BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM HEX ADJ SCRWDRVR BLADE W/SPADE POINT HXC(REPLACEMENT)

    MDR report key: 3020815 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10404
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    July 29, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 SUPPLIER'S CERTIFICATIONS INDICATE THE CORRECT MATERIAL WAS USED AND CORRECT HARDNESS VALUES WERE OBTAINED. THE DEVICE WAS RETURNED WITH THE TIP BROKEN OFF OF THE SHAFT. A SMALL PORTION OF THE BLADE REMAINS, BUT NOT ENOUGH FOR MEASUREMENT. THE TIP OF THE SHAFT HAS DENTS AND APPEARS BENT. THE MEASURABLE DIMENSIONS ARE WITHIN SPECIFICATION. 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. THE PRODUCT EVALUATION INVESTIGATION DETERMINED THE FOLLOWING: IT CAN BE INFERRED FROM THE AXIAL OUT-OF-PLANE BENDING OF THE SCREWDRIVER BLADES (351.035) THAT RADIAL FORCES (PERPENDICULAR TO THE CENTERLINE AXIS) WERE APPLIED TO THE SCREWDRIVER BLADES CAUSING THE BENDING OBSERVED. THE RADIAL FORCES WOULD MOST LIKELY HAVE BEEN APPLIED AT THE TIP OF THE SCREWDRIVER BLADE INDUCING INCREASED STRESS ON THE TIP. AN INCREASED STRESS IN THE TIP REGION WOULD REDUCE THE FATIGUE LIFE AND COULD LEAD TO BREAKAGE WITHIN THE REGION OF THE SMALLEST CROSS-SECTIONAL AREA (THE WEAKEST REGION) OVER REPEATED USE OF THE SIMILAR MANNER. NO DETAILS HAVE BEEN PROVIDED OF THE PROCEDURE AND CONDITIONS SURROUNDING THE TIP BREAKAGE. THEREFORE FROM A DESIGN PERSPECTIVE THE COMPLAINT IS INDETERMINATE BECAUSE OF THE LACK OF INFORMATION. TIP BREAKAGE IS COVERAGE IN THE RISK ASSESSMENT. ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.THERE WERE TWO RECEIPTS FOR THIS LOT NUMBER. THE ADDITIONAL PART MANUFACTURE DATE IS 1/28/09.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS HAD BROKEN OFF OF TWO 4.5MM HEX ADJUSTABLE SCREWDRIVERS. THE HOSPITAL DISCARDED THE BROKEN TIPS. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124386 4.5MM HEX ADJ SCRWDRVR BLADE W/SPADE POINT HXC(REPLACEMENT) HXX SYNTHES MONUMENT U101726

    Patients

    Seq Age Sex Outcome Treatment
    1