BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM CARBON FIBER ROD 75MM

    MDR report key: 7707610 · Received July 20, 2018

    Report

    Report Number
    8030965-2018-55196
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Report Date
    July 2, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819200050
    PMA / PMN Number
    K033158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: PART: 395.111; LOT: L210851; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 29. NOV. 2016. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SUMMARY: WE HAVE FORWARDED THE RECEIVED PART TO THE RESPONSIBLE MANUFACTURING SITE FOR FURTHER EVALUATION WITH THE FOLLOWING RESULTS (INVESTIGATION DOCUMENTED IN PI-15308094901173512): AS RELEVANT FOR THE COMPLAINT CONDITION THAT THE CARBON FIBRE RODS DO NOT FIT WITH THE CONNECTING CLAMP, THE RELEVANT FEATURES HAVEN BEEN IDENTIFIED AND MEASURED. SEVERAL MEASUREMENTS WERE TAKEN FOR EACH PART. FIRST THE PARTS WERE MEASURED AT THE SAME LOCATION IN DIFFERENT ORIENTATIONS AND SECOND, THE PARTS WERE MEASURED AT DIFFERENT LOCATIONS ALONG THE LENGTH OF THE ROD. THE MAXIMUM AND MINIMUM RESULTS WERE DOCUMENTED AND HAVE FAILED THROUGH THE SPECIFICATIONS ACCORDING TO THE DRAWING. ACCORDING TO THE INVESTIGATION RESULTS, THIS COMPLAINT IS CONFIRMED SINCE THE DIMENSIONAL TEST HAS FAILED TO MEET THE SPECIFICATIONS. THEREFORE, FROM THE MANUFACTURING POINT OF VIEW THIS COMPLAINT IS RATED AS VALID BECAUSE THE FINISHED GOODS PRODUCTS ARE NOT MANUFACTURED ACCORDING TO SPECIFICATION INDICATED BY THE DRAWINGS MENTIONED IN SECTION 2.3. A NON-CONFORMANCE HAS BEEN RAISED TO FURTHER INVESTIGATE THIS ISSUE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DATE OF EVENT IS UNKNOWN. ADDITIONAL PROCODE: JEY. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TEN CARBON FIBER RODS WOULD NOT FIT WITH THE CONNECTING CLAMP. SUBSTITUTE RODS WITH SAME PART NUMBERS WHERE USED INSTEAD. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM CARBON FIBER ROD 75MM. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548095 3.0MM CARBON FIBER ROD 75MM APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH L210851 07611819200050

    Patients

    Seq Age Sex Outcome Treatment
    1