BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAFIT PLUS 7 CUP ¿CAP SIZE 54MM H

    MDR report key: 6623069 · Received June 8, 2017

    Report

    Report Number
    9610612-2017-00322
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    May 11, 2017
    Report Date
    June 30, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    KWL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. 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: JAPAN. IT WAS REPORTED THAT DURING A THA (TOTAL HIP ARTHROPLASTY) AN INSTRUMENT COULD NOT BE REMOVED FROM THE CUP. AFTER REAMING THE SURGEON SET THE CUP WITH A CURVE IMPACTOR CONNECTED TO A DRIVER. ONCE THE SURGEON HAD THE CUP IN ITS PLACE HE ATTEMPTED TO REMOVE THE IMPACTOR FRO THE CUP. EVEN THOUGH THE IMPACTOR AND THE CUP WAS IN PLACE, NOW THE IMPACTOR COULD NOT BE REMOVED. THE CUP HAD TO BE REMOVED TO REMOVE THE IMPACTOR. THE PROCEDURE HAD TO BE COMPLETED BY USING ANOTHER CUP AND A STRAIGHT IMPACTOR. THERE WAS NO HARM TO THE PATIENT REPORTED. NO SURGERY DELAY. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00322, 9610612-2017-00323.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE DEVICES SHOW NO VISIBLE FAILURE OR SIGNIFICANT ABNORMALITIES. ALL DEVICES WERE INVESTIGATED VISUALLY. THE THREAD OF THE IMPACTOR AS WELL AS THE THREAD OF THE PLASMAFIT PLUS 7 CUP SHOWS NO DAMAGES OR ANY SURFACE DEFECTS. THE WORKING END OF THE SCREW DRIVER SW4.5 ALSO SHOWS NO SIGNIFICANT DAMAGES. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATIONS, VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. A POSSIBLE REASON FOR THIS FAILURE COULD BE THAT THE SURGEON APPLIED THE DEVICES WITH A HIGH LEVEL OF TORQUE. A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401936 PLASMAFIT PLUS 7 CUP ¿CAP SIZE 54MM H MPLANTS PLASMAFIT KWL AESCULAP IMPLANT SYSTEMS NC954T 52170555

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other