BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIOS OSTEOTOME CVD

    MDR report key: 6535476 · Received May 1, 2017

    Report

    Report Number
    9610612-2017-00222
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    February 21, 2017
    Report Date
    April 6, 2018
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HWM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT WAS REPORTED THAT THE OSTEOTOME TIP CRUMPLED DURING BONE RESECTION. NO HARM TO THE PATIENT WAS REPORTED. THERE WAS A FIFTEEN MINUTE DELAY IN SURGERY DUE TO HAVING TO FIND AN ALTERNATE OSTEOTOME. QUANTITY OF EFFECTED DEVICES WAS UNKNOWN WHEN ORIGINAL MED WATCH WAS SUBMITTED. THIS SUBMISSION IS RELATED TO REPORT MDR# 9610612-2017-00170.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT. HERE WE FOUND A VISIBLY DAMAGED CUTTING EDGE. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD, A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. THE INSTRUMENT IS USED FOR THE COMPLETE REMOVAL OF TIBIAL BONE RESECTED. THE BONE IS SOFTER THEN THE CUTTING EDGE HAD CONTACT WITH METAL PARTS, SUCH AS IMPLANT OR PIN DURING SURGERY. THERE IS THE POSSIBILITY FOR A PRE-DAMAGE OR SIMILAR DUE TO PREVIOUS SURGERIES SINCE THE LAST APPROXIMATELY 10 YEARS, BY OVERSTRAINING. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315886 MIOS OSTEOTOME CVD NSTRUMENTS FOR KNEE ENDOPROST HWM AESCULAP IMPLANT SYSTEMS NQ948R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other