BEUDAMED
    FDA Adverse Event Other Summary report: N

    GOTFRIED PCCP NECK SCREWDRIVER

    MDR report key: 1586324 · Received January 18, 2010

    Report

    Report Number
    9680825-2010-00001
    Event Type
    Other
    Date Received
    January 18, 2010
    Date of Event
    October 4, 2009
    Report Date
    January 18, 2010
    Manufacturer
    ORTHOFIX SRL
    Product Code
    JDO
    PMA / PMN Number
    K983814
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS THE REPORT WAS RECEIVED, ORTHOFIX IMMEDIATELY STARTED THE CASE EVAL: THE SCREWDRIVER CONTAMINATION WAS DETECTED PRIOR TO USE AND DID NOT HAVE ANY PT CONTACT AND NO PT EFFECT. THE EVENT DID NOT LEAD TO SERIOUS INJURY. THE PRODUCT INVOLVED WAS NOT DISASSEMBLED AND PROPERLY CLEANED BEFORE STERILIZATION, AS RECOMMENDED IN THE IFU (PQ ISP, PQ PCP) AND SHOWN IN THE OPTECH (PM PCP). THE INSTRUCTIONS FOR THE SAFE PROCESSING OF THE ORTHOFIX PRODUCTS ARE REPORTED IN THE LEAFLET PQ ISP PROVIDED WITH THE ORTHOFIX PRODUCTS. IN ADDITION, THE RELATED OPTECH (PM PCP) CLEARLY STATES TO "DISASSEMBLE THE NECK SCREWDRIVER FOR THOROUGH CLEANING AND DISINFECTION PRIOR TO STERILIZATION". THEREFORE, THE EVENT IS NOT A PRODUCT MALFUNCTION. IT IS NORMAL PRACTICE (AND IT IS SPECIFICALLY RECOMMENDED IN THE ORTHOFIX LEAFLET PQ ISP) TO PERFORM A VISUAL INSPECTION ON THE PRODUCTS AFTER DECONTAMINATION ACTIVITIES AND BEFORE STERILIZATION. THEREFORE, EVEN IF THE EVENT WERE TO RECUR, IT MAY NOT CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR OTHER SIGNIFICANT ADVERSE EVENT AS PRODUCTS NOT PROPERLY CLEANED DO NOT COME IN CONTACT WITH PTS. ORTHOFIX CONCLUDES THAT THE EVENT DOES NOT MEET THE REQUIREMENTS FOR MANDATORY REPORTING. FOR OUR RECORDS, NO SIMILAR EVENTS HAVE EVER BEEN REPORTED. IN ORDER TO AVOID RE-OCCURRENCE OF THIS EXTRA-ORDINARY EVENT AT THIS FACILITY, ORTHOFIX HAS IMMEDIATELY IMPLEMENTED TWO SEPARATE IN-SERVICE TRAINING MEETINGS WITH ALL PERTINENT HOSP STAFF MEMBERS, TO REINFORCE PROPER CLEANING OF ALL ITEMS INCLUDED IN THE PCCP TRAY.

    Description of Event or Problem · 1

    EVENT DESCRIPTION TAKEN FROM THE MEDWATCH FILED BY THE INVOLVED HOSP: "VENDOR TRAY BROUGHT IN FOR PROCEDURE. STERILE PROCESSING DEPT TECH WENT THROUGH TRAY WITH VENDOR AND ASKED THE MFR REP IF THERE WERE ANY TROUBLE AREAS WITH THE INSTRUMENTS AND IF THE INSTRUMENTS CAME APART. THE REP REPLIED NO. THE TRAY WAS PROCESSED THROUGH DECONTAMINATION, WRAPPED AND STERILIZED FOR A CASE THE NEXT DAY. THE SCRUB TECH WAS EXAMINING THE TRAY BEFORE THE PROCEDURE AND TOOK APART A SCREWDRIVER. THERE WAS BLOOD BETWEEN THE TWO PARTS. THE TWO PARTS WERE TAKEN TO DECONTAMINATION TO REPROCESS. IN DECONTAMINATION, THE SCREWDRIVER CAME APART EVEN FURTHER INTO THREE PARTS. THERE WAS DEBRIS BETWEEN THOSE PARTS ALSO. THIS OCCURRED PRIOR TO REACHING THE STERILE FIELD - SO NEVER REACHED THE PT, BUT DID CAUSE A DELAY IN THE CASE". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOTFRIED PCCP NECK SCREWDRIVER GOTFRIED PCCP NECK SCREWDRIVER JDO ORTHOFIX SRL 184000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other