BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 7801314 · Received August 21, 2018

    Report

    Report Number
    8030965-2018-55843
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    July 24, 2018
    Report Date
    July 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. THIS REPORT IS FOR AN UNKNOWN RFN SPIRAL BLADE. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE HAS NOT BEEN EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER EMAIL ADDRESS IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6), OPEN REDUCTION INTERNAL FIXATION WITH EXPERT ANTEGRADE FEMORAL NAIL (AFN) (B)(6) SYSTEM (200MM, 13MM DIAMETER) WAS APPLIED TO OBLIQUE FRACTURE BETWEEN THE DIAPHYSIS AND DISTAL PARTS OF THE FEMUR. AFTER A LOCKING SCREW AND EXPERT RETROGRADE FEMORAL NAIL (RFN) SPIRAL BLADE WERE INSERTED FOR DISTAL SIDE STOPPING, THE SURGEON MOVED TO THE PROCESS OF PROXIMAL SCREW INSERTION. [INTERFERENCE BETWEEN DRILL BIT AND NAIL]: WHEN THE SURGEON TRIED TO DRILL THE BONE FOR THE SECOND MOST PROXIMAL SCREW HOLE ON THE NAIL, THE DRILL BIT INTERFERED WITH THE NAIL. THE DRILL BIT PENETRATED THE LATERAL SIDE OF THE CORTICAL BONE AND WENT INTO THE BONE. HOWEVER, IT DID NOT PENETRATE THE MEDIAL SIDE OF THE CORTICAL BONE. [INSERTION OF END CAP (1)]: AFTER THE CONNECTING SCREW (EXPERT RFN) WAS REMOVED, THE SURGEON TRIED TO INSERT THE END CAP INTO THE NAIL USING A SCREW DRIVER WITH TYPE T40 THROUGH THE INSERTION HANDLE. HOWEVER, THE END CAP COULD NOT BE INSERTED. [REMOVAL OF BLADE INSERTER]: THE SURGEON TRIED TO REMOVE THE CONNECTING SCREW FROM THE BLADE TO DISASSEMBLE THE DEVICES. HOWEVER, IT WAS VERY HARD TO DO THIS SINCE THE SCREW HAD BEEN TIGHTENED ON THE BLADE TOO FIRMLY. FINALLY, THE SURGEON SOMEHOW COULD DO THIS USING A PIN WRENCH AND OTHER TOOLS. [INSERTION OF END CAP (2)]: WHILE THE SURGEON TRIED TO INSERT THE END CAP, IT EASILY CAME OFF THE SCREW DRIVER WITH T40 TYPE INSIDE THE PATIENT¿S BODY. ALSO, IT WAS VERY HARD TO RE-ATTACH THE END CAP TO THE SCREW DRIVER INSIDE THE PATIENT¿S BODY. FINALLY, THE SURGEON SOMEHOW SUCCEEDED IN IT, AND COULD INSERT THE SCREW. THE PROXIMAL SCREW WAS INSERTED USING A POWER TOOL. THE SURGEON DRILLED THE BONE USING A DRILL BIT WITH 4.0 DIAMETER, THEN COULD INSERT THE SCREW SUCCESSFULLY. THE SURGERY WAS DELAYED WITH 40 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON COMMENTED THAT THERE WAS NO DRY RUN TO TEST. CONCOMITANT DEVICES: PERCUTANEOUS INSERTION HANDLE (PART: 03.010.046, LOT: L463603, QUANTITY: 1); 12.0MM/8.0MM PROTECTION SLEEVE 188MM (PART: 03.010.063, LOT: L376013, QUANTITY: 1); 8.0MM/4.2MM DRILL SLEEVE 200MM (PART: 03.010.065, LOT: L467704, QUANTITY: 1); 4.2MM TROCAR 210MM (PART: 03.010.070, LOT: 9747135, QUANTITY: 1); 15.0MM/13.0MM PROTECTION SLEEVE WITH SPIRAL BLADE AIMING ARM (PART: 03.010.081, LOT: 9853397, QUANTITY:1); 13.0MM/3.2// WIRE GUIDE FOR SPIRAL BLADE AIMING ARM (PART: 03.010.082, LOT: 9853394, QUANTITY: 1); SPIRAL BLADE INSERTER FOR RFN ¿ EXPERT (PART: 03.010.084, LOT: 9853390, QUANTITY: 1); ARM FOR PROXIMAL AIMING DEVICE FOR RFN ¿ EXPERT 160MM-200MM (PART: 03.010.142, LOT: L416112, QUANTITY: 1); MODULE FOR SPIRAL BLADE LOCKING FOR PROXIMAL AIMING DEVICE FOR FMN 160MM-200MM (PART: 03.010.144, LOT: L439478, QUANTITY: 1); CANNULATED CONNECTING SCREW WITH INTERNAL THREAD FOR PERCUTANEOUS INSERTION HANDLE (PART: 03.010.146, LOT: U259224, QUANTITY: 1); ANTEGRADE FEMORAL NAIL ¿ EXPERT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN UNKNOWN RFN SPIRAL BLADE. THIS IS REPORT 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643182 ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1