BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERTER FOR TI ELASTIC NAILS

    MDR report key: 8533551 · Received April 19, 2019

    Report

    Report Number
    8030965-2019-62987
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 27, 2019
    Report Date
    March 29, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819096653
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. PART: 359.219; LOT: L982608; MANUFACTURING SITE: HAEGENDORF; RELEASE TO WAREHOUSE DATE: OCTOBER 16, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE HAMMER GUIDE IS COMPLETELY STUCK IN THE INSERTER. ALSO, IT WAS FOUND THAT THE CHUCK IS COMPLETELY STUCK; OPENING AND CLOSING OF THE JAWS IS NOT POSSIBLE. THERE ARE HEAVY DAMAGES VISIBLE AT THE KNURLED SURFACE. FUNCTION TEST: THE DEVICES ARE COMPLETELY STUCK; DISASSEMBLING IS IMPOSSIBLE. THEREFORE, NO FUNCTION TEST CAN BE PERFORMED. DIMENSIONAL INSPECTION: THE DEVICES ARE COMPLETELY STUCK; DISASSEMBLING IS IMPOSSIBLE. THEREFORE, THE DIMENSIONS CANNOT BE VERIFIED. DRAWING/SPECIFICATION REVIEW: AS NEITHER A FUNCTION TEST NOR A DIMENSION INSPECTION CAN BE PERFORMED, ADDITIONAL REVIEW OF THE MANUFACTURING DOCUMENTS OF THE SHAFT SUB-COMPONENT WAS MADE. POTENTIALLY USED WORK ORDERS WERE REVIEWED. NONE OF THOSE WORK ORDERS CONTAINS A NON-CONFORMANCE, THE RELEVANT G 1/8" THREAD AND THE HARDNESS WERE CHECKED AS REQUIRED DURING THE MANUFACTURING PROCESS. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE HAMMER GUIDE IS STUCK IN THE INSERTER AS COMPLAINED. THE EXACT ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DEFINED AS THE DEVICES CANNOT BE DISASSEMBLED. THERE IS NO INDICATION OF A MANUFACTURING RELATED ISSUE. THIS LOT WAS MANUFACTURED IN OCTOBER 2018 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. IT CAN ONLY BE ASSUMED THAT EITHER THE THREAD OF THE INSERTER OR THE THREAD OF THE HAMMER GUIDE DID GET DAMAGED DURING USE. THE CHUCK OF THE INSERTER IS ALSO STUCK; THIS DAMAGE CAN BE TRACED BACK TO THE EXCESSIVE HAMMER MARKS AT THE SURFACE. IT CANNOT BE DEFINED IF THIS WAS CAUSED DURING USE OR DURING THE DISASSEMBLING ATTEMPT OF THE JAMMED DEVICES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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 · 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 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

    THE DEVICE HAS BEEN 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 DURING A TITANIUM ELASTIC NAILING SYSTEM (TENS) NAILING FOR A FEMUR FRACTURE PROCEDURE ON (B)(6) 2019, AN INSERTER FOR TENS AND HAMMER GUIDE FOR TEN WAS STUCK TOGETHER. THE USER WAS UNABLE TO TAKE THEM APART. ANOTHER TENS SET WAS UTILIZED TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETE WITH NO ADVERSE CONSEQUENCE TO THE PATIENT. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) INSERTER FOR TI ELASTIC NAILS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323835 INSERTER FOR TI ELASTIC NAILS MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH L982608 07611819096653

    Patients

    Seq Age Sex Outcome Treatment
    1