BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTION SCREW FOR PFNA BLADE

    MDR report key: 9771086 · Received February 28, 2020

    Report

    Report Number
    8030965-2020-01548
    Event Type
    Malfunction
    Date Received
    February 28, 2020
    Report Date
    February 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819349483
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. VISUAL INSPECTION: UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT WE HAVE RECEIVED THE BLADE ATTACHED TO THE EXTRACTION SCREW. IN ADDITION, THE RECEIVED DEVICE SHOWS SIGNS OF USE ALL OVER THE PART. ESPECIALLY THE TOP T-BAR PART SHOWS MARKS FROM HAMMERING (FOR DETAILS SEE PICTURE ATTACHED "(B)(4)- PICTURES FROM RECEIVED PARTS.PDF"). FUNCTIONAL TEST: DURING INVESTIGATION WE WERE ABLE TO DETACH THE BLADE FROM THE EXTRACTION SCREW, AND A FUNCTIONAL TEST WAS PERFORMED, BOTH PARTS PASSED THE FUNCTIONAL TEST (FOR DETAILS SEE PICTURE ATTACHED "(B)(4)- PICTURES FROM RECEIVED PARTS.PDF"). SUMMARY: THE COMPLAINT IS RATED AS UNCONFIRMED AND NOT VALID FROM MANUFACTURING POINT OF VIEW, AS THE PART IS FULLY FUNCTIONAL, THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY PART NUMBER: 03.010.411, LOT NUMBER: L019753, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 22. JUNE 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL PRO-CODE: HWB. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A LOAN KIT INSPECTION, A FNA BLADE 04.027.036 HAS SEIZED ONTO FNA EXTRACTOR 03.010.411. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR PFNA BLADE. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233786 EXTRACTION SCREW FOR PFNA BLADE SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH L019753 07611819349483

    Patients

    Seq Age Sex Outcome Treatment
    1