BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIPER IN & OUT DIA TO 150MM

    MDR report key: 8480380 · Received April 3, 2019

    Report

    Report Number
    9610612-2019-00201
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Report Date
    April 3, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    KTZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: INVESTIGATION: THE CALIPER WAS AVAILABLE FOR INVESTIGATION DECONTAMINATED. THE CALIPER WAS IN MINT CONDITION, BUT ONE OF THE ADJUSTMENT SCREWS WAS NOT IN PLACE. THE SCREW IS NOT AVAILABLE. BATCH HISTORY REVIEW: A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS WAS NOT POSSIBLE BECAUSE THE LOT NUMBER IS UNKNOWN. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONALE: THE ADJUSTMENT SCREWS ARE NECESSARY TO ADJUST THE MOVEMENT OF THE SLIDING PART OF THE CALIPER, THUS THEY NEED TO BE MOVEABLE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE INSTRUMENT MUST BE CHECKED PRIOR TO EACH USE FOR LOOSENED COMPONENTS: INSPECTION, MAINTENANCE AND CHECKS: AFTER EACH COMPLETE CLEANING, DISINFECTING AND DRYING CYCLE, CHECK THAT THE PRODUCT IS DRY, CLEAN, OPERATIONAL, AND FREE OF DAMAGE. CHECK THAT THE PRODUCT FUNCTIONS CORRECTLY. IMMEDIATELY PUT ASIDE DAMAGED OR INOPERATIVE PRODUCTS AND SEND THEM TO AESCULAP TECHNICAL SERVICE. A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS AN INTRAOPERATIVE ISSUE WITH THE CALIPER. DURING A HIP SURGERY, IT WAS NOTED THAT THE SCREW WAS MISSING FROM THE CALIPER. THE CALIPER WAS BEING USED ON THE BACK TABLE AND NOT DIRECTLY IN THE OPERATIVE FIELD. THE REPORTER FELT THAT THE SCREW BECOMES LOOSE AND SEPARATES TOO EASILY. THERE WAS NO PATIENT HARM AND AN X-RAY WAS NOT REQUIRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273489 CALIPER IN & OUT DIA TO 150MM BASIC INSTRUMENTS KTZ AESCULAP AG AA846R

    Patients

    Seq Age Sex Outcome Treatment
    1