BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    . EXTRACTION SCREW . FOR PFNA BLADE

    MDR report key: 9812731 · Received March 10, 2020

    Report

    Report Number
    8030965-2020-01773
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Report Date
    February 13, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H3, H6: INVESTIGATION SUMMARY INVESTIGATION SELECTION INVESTIGATION SITE: (B)(4), SELECTED FLOW : DEVICE INTERACTION / FUNCTIONAL. VISUAL INSPECTION THE MOUNTING THREAD ON THE TIP OF THE EXTRACTION SCREW FOR PFNA BLADE IS BLOCKED IN THE PFNA BLADE. THE EXTRACTION SCREW FOR PFNA BLADE IS INTACT AND BESIDE SOME MINOR MARKS DOES NOT SHOW DAMAGES. IT IS NOT POSSIBLE TO DETACH BOTH PART FROM EACH OTHER. FUNCTIONAL TEST/ DIMENSIONAL INSPECTION: A FUNCTIONAL TEST AND DIMENSIONAL INSPECTION CANNOT BE PERFORMED BECAUSE THE DEVICES ARE BLOCKED TOGETHER. DOCUMENT/SPECIFICATION REVIEW THE MANUFACTURING REVIEW OF BOTH PARTS, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT IS CONFIRMED AS BOTH DEVICES ARE BLOCKED TOGETHER. THE VISUAL APPEARANCE OF THE BLOCKED PFNA BLADE SHOWS THAT BOTH DEVICES WERE SUBJECTED TO MECHANICAL OVERLOAD. THE PFNA BLADE HAS VARIOUS DAMAGES THAT OCCURRED DURING THE IMPLANTATION TIME OR DURING ATTEMPTS TO REMOVE THE BLADE FROM THE INSTRUMENT. THE INSIDE ATTACHING AND LOCKING MECHANISM OF THE PFNA BLADE IS DAMAGED AND NOT FUNCTIONING ANYMORE. ALL ATTEMPTS TO REMOVE THE BLADE FROM THE EXTRACTION SCREW FOR PFNA BLADE WERE UNSUCCESSFUL. THE REPORTED FAILURE IS TYPICALLY CONSISTENT WITH INADEQUATE HANDLING OF THE DEVICE IN COMBINATION WITH EXCESSIVE FORCE APPLICATION. BASED ON THE FINDINGS ABOVE NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, AS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 03.010.411, LOT: L697081, MANUFACTURING SITE: BETTLACH, RELEASE TO WAREHOUSE DATE: 17.JAN 2018. 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

    PATIENT INFORMATION IS UNKNOWN. IMPLANT DATE: UNKNOWN. EXPLANT DATE: UNKNOWN. ADDITIONAL PRODUCT CODE: HWB. OCCUPATION: SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON AN UNKNOWN DATE THAT DURING AN UPCOMING INSPECTION AT THE LOANER SET DEPARTMENT AT DPS, UMKIRCH, IT WAS NOTICED THAT THE BLADE CANNOT BE DISASSEMBLED. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. THIS IS 1 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275522 . EXTRACTION SCREW . FOR PFNA BLADE SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH L697081 07611819349483

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTRACTSCR F/PFNA BLADE| UNK - NAIL HEAD ELEMENTS: PFNA BLADE