BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION GUIDE

    MDR report key: 8808128 · Received July 19, 2019

    Report

    Report Number
    8030965-2019-66412
    Event Type
    Injury
    Date Received
    July 19, 2019
    Date of Event
    June 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819117525
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. SHIPPED BACK DEVICE ¿PHILOS AIM-DEVICE¿ WITH LOT NUMBER 9120123 IS IN USED CONDITIONS. SCRATCHES ARE VISIBLE ON THE DEVICE AND THE CENTRAL THREAD IS DAMAGED AND BROKEN. THE RETURNED SCREW IS ALSO BROKEN. FUNCTIONAL TESTS ARE NOT REQUIRED FOR SELECTED INVESTIGATION FLOW IN W-M-S080 APPENDIX A AND DUE TO THE FACT THAT THE DEVICE IS BROKEN, IT IS NOT POSSIBLE TO PERFORM THEM ANYMORE. THE DEVICE IS HEAVILY DAMAGED AND FOR THIS REASON IS NOT POSSIBLE TO PERFORM MEASUREMENTS. IN PARTICULAR, AS STATED IN THE COMPLAINT DESCRIPTION, IT WAS USED A DRILL THAT DAMAGED THE DEVICE ALTERING DIMENSIONS AND FUNCTIONS. ACCORDING TO EVIDENCES IS NOT POSSIBLE TO ADDRESS THE FINAL ROOT CAUSE TO A MANUFACTURING ISSUE. THE MANUFACTURING PROCESS WAS PERFORMED AND DOCUMENTED IN THE INSPECTION SHEETS AND ALL FUNCTIONAL TESTS WERE RECORDED. MISUSE OF THE DEVICE IS MOST LIKELY TO ADDRESS AS ROOT CAUSE. SINCE NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. DEVICE HISTORY LOT PART: 323.050, LOT: 9120123, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 21.OCTOBER 2014 . 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR PROXIMAL HUMERAL FRACTURE, THE SURGEON PLACED AN UNKNOWN PLATE USING A PHILOS AIM-DEVICE. AFTER AN INSERTION OF THE SCREWS INTO THE PLATE WAS COMPLETED, THE SURGEON TRIED TO REMOVE AN AIM-DEVICE FROM THE PLATE. HOWEVER, THE HEXAGONAL RECESS ON AN ATTACHMENT SCREW OF THE AIM-DEVICE HAD ALREADY WORN AWAY AT THAT TIME. CONSEQUENTLY, IT BECAME HARD TO REMOVE THE ATTACHMENT SCREW FROM AN AIM-DEVICE. THEN, THE SURGEON TRIED TO USE AN UNKNOWN TWO (2) LOANER SCREWDRIVER SHAFTS AND ONE (1) SCREWDRIVER SHAFT POSSESSED BY THE HOSPITAL, BUT STILL, THE SCREW COULD NOT BE REMOVED DUE TO THE TIP OF THE SCREWDRIVERS COULD NOT BE ENGAGED WITH THE HEXAGONAL RECESS ON THE ATTACHMENT SCREW. MOREOVER, THE SURGEON TRIED VARIOUS WAYS SUCH AS HAMMERING, INSERTING A PIECE OF ALUMINUM FOIL INTO THE RECESS AND USING AN UNKNOWN EXTRACTION SCREW BUT DID NOT SUCCEED. FINALLY, THE SURGEON BROKE THE SCREW USING AN UNKNOWN CARBIDE DRILL, THEN, REMOVED THE AIM-DEVICE AND THE REMAINING PIECE OF THE BROKEN SCREW WAS REMOVED USING AN UNKNOWN PLIERS. THE SURGERY WAS COMPLETED WITH A 30 MINUTES DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENDED THAT THE TIP OF THE LOANER DRIVER SHAFT MIGHT HAVE WORN AWAY. PATIENT STATUS IS UNKNOWN.  CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER SHAFT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1), UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN) . THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599699 INSERTION GUIDE GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 9120123 07611819117525

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention