BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 2111609 · Received June 2, 2011

    Report

    Report Number
    2090040-2011-00008
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 7, 2011
    Manufacturer
    ASCENT
    Product Code
    KTT
    PMA / PMN Number
    K032058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE CONSISTED OF SEVERAL DIFFERENT PARTS WHICH WERE ALL RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS WITHOUT THE ORIGINAL PACKAGING MATERIALS SO INFORMATION SUCH AS LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE WERE NOT AVAILABLE. THE BOLT ASSOCIATED WITH EACH CLAMP WAS OBSERVED TO BE SEVERED. THE FRACTURED COMPONENTS WERE SENT TO A THIRD PARTY FOR ANALYSIS. BOLT #1 IN THE DEVICE WAS SEIZED UP AND UNABLE TO ROTATE FREELY IN THE CLAMP WHEREAS BOLT #2 WAS EASILY REMOVED FROM THE CLAMP. THE BOLTS WERE ANALYZED USING SCANNING ELECTRON MICROSCOPY. ACCORDING TO THE ANALYSIS, BOLT #1 CONTAINED SMOOTH FRACTURE SURFACES WHICH INDICATES A DUCTILE RUPTURE. THE FRACTURE IS SPIRAL-SHAPED WHICH DEMONSTRATES A TENSION STRESS COMPONENT. THE SPIRAL DEFORMATION BANDS APPEAR TO BE ORIENTED IN A WAY THAT INDICATES THAT THE FAILURE OCCURRED WHILE TIGHTENING THE BOLT. THE CAUSE OF THE FAILURE ON BOLT #1 IS TORSION OVERLOAD WHILE IN TENSION DUE TO OVER-TIGHTENING OF THE BOLT IN THE CLAMP ASSEMBLY. ACCORDING TO THE ANALYSIS, BOLT #2 CONTAINED FRACTURES SURFACES THAT WERE VERY SMOOTH AND ORTHOGONAL TO THE LONG AXIS OF THE BOLT INDICATING A DUCTILE RUPTURE IN PURE TORSION. SPIRAL DEFORMATION BANDS AT THE FRACTURE SITE ARE ALSO INDICATIVE OF SEVERE DEFORMATION PRIOR TO FAILURE. THE DIRECTIONALITY OF THE SPIRAL BANDS SHOWS THE FAILURE OCCURRED DURING AN ATTEMPT TO LOOSEN THE SEIZED BOLT. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATES: "INTRAOPERATIVE FRACTURE OR BREAKAGE OF INSTRUMENTS CAN OCCUR (E.G. DUE TO EXCESSIVE FORCE, EXTENSIVE USE). INSPECT ALL EXTERNAL FIXATION DEVICES AND COMPONENTS PRIOR TO SURGERY. REPLACE WHEN NECESSARY." "DO NOT APPLY EXCESSIVE FORCE TO EXTERNAL FIXATION DEVICES." THIS IS THE FIRST COMPLAINT OF THIS NATURE THAT STRYKER SUSTAINABILITY SOLUTIONS HAS RECEIVED.

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT THE DEVICE INVESTIGATION HAS NOT BEEN COMPLETED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLAMPS ON THE EXTERNAL FIXATION DEVICE FAILED TO HOLD THE RODS IN PLACE. THE PATIENT HAD TO HAVE AN ADDITIONAL SURGERY TO RE-SET THE FRACTURE AND REPLACE THE CLAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A KTT KTT ASCENT 390.007

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R