BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHN MULTILOC Ø9.5 IZQ CAN L160 TAN

    MDR report key: 13653743 · Received March 2, 2022

    Report

    Report Number
    8030965-2022-01293
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    UDI-DI
    07611819431058
    PMA / PMN Number
    K103002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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. H6: THE PHOTO WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT THE PHN MULTILOC Ø9.5 IZQ CAN L160 TAN WAS BROKEN FROM THE PROXIMAL TIP, ACCORDING TO PRE AND POSTOPERATIVE X-RAY EVIDENCE PROVIDED, FRAGMENT REMAINED IN PATIENT. UNABLE TO ASSEMBLE CONDITION CANNOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED FOR THE PHN MULTILOC Ø9.5 IZQ CAN L160 TAN. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PRODUCT CODE: 04.016.039S, LOT NUMBER: 93P0626, MANUFACTURING SITE: MEZZOVICO , RELEASE TO WAREHOUSE DATE: 30 APR 2021, EXPIRATION DATE: 01 APR 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE STERILE 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.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS. AFTER SURGERY, ON (B)(6) 2022, THE REMOVAL SURGERY WAS PERFORMED DURING WHICH, HAD A LITTLE DIFFICULTY IN CONNECTING THE EXTRACTION SCREW TO THE NAIL BUT REMOVED THE NAIL NORMALLY IN THE END. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER THE REVISION SURGERY, WHEN THE SURGEON GAVE EXPLANATIONS TO THE PERSONS CONCERNED WITH THE PATIENT, IT WAS FOUND THAT A NEEDLE-LIKE WHITE SHADOW WAS REFLECTED IN THE X-RAY. THEREFORE, THE SURGEON CHECKED ALL THE MATERIALS USED IN THE OPERATION ROOM, INCLUDING NEEDLES, BUT DID NOT FIND ANY BROKEN ONES. WHEN THE REMOVED IMPLANTS WERE CHECKED, BREAKAGE WAS CONFIRMED AT THE THREADED PART OF THE NAIL THAT CONNECTS AN END CAP. THE SURGEON CHECKED THE X-RAY AFTER THE REMOVAL SURGERY BUT COULD NOT FIND ANYTHING LIKE NEEDLE-LIKE WHITE SHADOW AT THAT TIME. THE SURGEON COMMENTED AS FOLLOWS. WHEN THE EXTRACTION SCREW WAS CONNECTED TO THE NAIL, THE METAL CAME INTO CONTACT WITH EACH OTHER, AND THE LOAD ON THE THREADED PART CAUSED THE THREADED PART OF THE NAIL TO SHAVE OFF. AS A RESULT, DEBRIS WAS CREATED AND REMAINED IN THE BODY. THE COURSE WILL BE FOLLOWED UP FOR NOW. THE PLAN OF REOPERATION HAS NOT BEEN DECIDED YET. THIS REPORT IS FOR ONE (1) PHN MULTILOC Ø9.5 IZQ CAN L160 TAN. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339108 PHN MULTILOC Ø9.5 IZQ CAN L160 TAN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH 93P0626 07611819431058

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male EXTRACTSCR F/ML HUM NAIL