BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE

    MDR report key: 3844593 · Received June 3, 2014

    Report

    Report Number
    0008031020-2014-00268
    Event Type
    Malfunction
    Date Received
    June 3, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT OF THE DEBRIS IN THE CANNULATED SCREWDRIVER ASNIS III COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE MOST PROBABLY WAS A USER RELATED ISSUE. FOR SUFFICIENT CLEANING PLEASE PAY ATTENTION TO THE INSTRUCTIONS IN THE OPERATIVE TECHNIQUE ASNIS III CANNULATED SCREW SYSTEM AND THE INSTRUCTIONS FOR USE. OPERATIVE TECHNIQUE (LITERATURE NUMBER: 982187 REV. 4): ¿ALL NON-STERILE DEVICES MUST BE CLEANED AND STERILIZED BEFORE USE. FOLLOW THE INSTRUCTIONS PROVIDED IN OUR REPROCESSING GUIDE (L24002000). MULTI-COMPONENT INSTRUMENTS MUST BE DISASSEMBLED FOR CLEANING. PLEASE REFER TO THE CORRESPONDING ASSEMBLY/DISASSEMBLY INSTRUCTIONS. [¿] ADDITIONAL INFORMATION CLEANING: CARE SHOULD BE TAKEN TO UTILIZE THE CLEANING STYLET FOR INTER AND POST-OPERATIVE CLEANING OF CANNULATIONS. CORRECT INTER-OPERATIVE USE OF THIS INSTRUMENT PREVENTS ACCUMULATION OF DEBRIS.¿ [ORIGINAL STATEMENT] IFU V15011/J: ¿CLEANING, MAINTENANCE AND STERILIZATION OF NON-STERILE INSTRUMENTS SUPPLIED IN A NON-STERILE CONDITION, MUST BE SUBJECTED TO AN APPROPRIATE CLEANING PROCESS BEFORE USE (DISMANTLING MAY BE NECESSARY) AND THEN STERILIZED BY MEANS OF A VALIDATED STEAM STERILIZATION PROCEDURE. [¿] THE FOLLOWING PROCESS PARAMETERS ARE VALIDATED BY STRYKER AND RECOMMENDED FOR STERILIZATION AND/OR RESTERILIZATION: METHOD (US): MOIST-HEAT STERILIZATION CYCLE: PRE-VACUUM (PRE-VAC) TEMPERATURE: 270° F (132° C) EXPOSURE TIME: 4 MINUTES PRESSURE: 2-15 PSIA DRY-TIME: 30 MINUTES (MINIMUM, IN CHAMBER) COOL-TIME: 60 MINUTES (MINIMUM, AT ROOM TEMPERATURE) METHOD (O/US): MOIST HEAT STERILIZATION ACCORDING TO EN ISO 17665-1 CYCLE: SATURATED STEAM WITH FORCED AIR REMOVAL EXPOSURE TIME: 4 MINUTES DRYING TIME: 30 MINUTES (RECOMMENDED MINIMUM, IN CHAMBER) TEMPERATURE: 132 - 137°C (270 - 277°F) NOTE: NOT FOR PRION INACTIVATION NOTE: ANY CYCLE SHOULD BE VALIDATED FOR DIFFERENT STERILIZATION CHAMBERS, WRAPPING METHODS AND/OR VARIOUS LOAD CONFIGURATIONS¿ [ORIGINAL STATEMENT] A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCRUB TECH, PRIOR TO SURGERY FOUND DEBRIS IN CANNULA 4.0 SCREW DRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCRUB TECH, PRIOR TO SURGERY FOUND DEBRIS IN CANNULA 4.0 SCREW DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324153 CANNULATED SCREWDRIVER ASNIS III HEX 2.5MM ELASTOSIL HANDLE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER TRAUMA SELZACH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other