BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 6269207 · Received January 22, 2017

    Report

    Report Number
    2520274-2017-10221
    Event Type
    Injury
    Date Received
    January 22, 2017
    Date of Event
    December 29, 2016
    Report Date
    December 29, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE, UNKNOWN EXPERT R/AFN NAIL 13MM X 340MM. PART AND LOT NUMBER ARE NOT AVAILABLE FOR REPORTING. OTHER NUMBER¿UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. BASED ON DEVICE DESCRIPTION, THE 13MM X 340MM R/AFN NAIL MAY BE PART NUMBER 04.013.748, BRAND NAME¿13MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/340MM; DEVICE PRODUCT CODES¿HSB, HWC; COMMON NAME--ROD, FIXATION, INTRAMEDULLARY; 510(K) K033618, (B)(4), LOT NUMBER UNKNOWN. WITHOUT A PART NUMBER; HOWEVER, THIS CANNOT BE CONFIRMED. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE DATE OF MANUFACTURE IS UNKNOWN. (B)(4). 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 REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT A TRANSVERSE FEMORAL FRACTURE WITH A POSTERIOR FRAGMENT WITH AN UNKNOWN NAIL SYSTEM, THE FIRST DISTAL SCREW MISSED THE NAIL POSTERIORLY AND THE NAIL CUT OUT OF THE CONDYLES ANTERIORLY. THE CANAL WAS QUITE LARGE. THE ENTRY POINT WAS REPORTEDLY CORRECT. THE SURGEON OPENED WITH THE 13MM ENTRY DRILL BIT THEN STRUGGLED TO GET THE GUIDE WIRE INTO THE CANAL. A REDUCTION TOOL WHICH WAS MORE RIDGED THAN THE WIRE WAS THEN USED. THE REAMING WIRE WAS DROPPED INTO THE PROXIMAL FRAGMENT AND THEN THE FEMUR WAS REAMED TO 14.5MM WHICH DID NOT TOUCH THE INNER CANAL. AN UNKNOWN 13MM X 340MM EXPERT RETROGRADE ANTEGRADE FEMORAL (R/AFN) NAIL WAS USED. THE JIG AND AIMING ARM WERE TESTED BEFORE INSERTION AND ALL HOLES LINED UP. THE NAIL WAS INSERTED THE NAIL, THE DISTAL SCREW WAS LOCKED, THEN THE BLADE. THE PROXIMAL LOCKING ANTEROPOSTERIOR (AP) WAS PERFORMED WITH A SINGLE UNKNOWN 5MM SCREW. A CONTROL AP X-RAY WAS TAKEN AND EVERYTHING ALL LOOKED GOOD BUT ON THE LATERAL X-RAY, THE FIRST DISTAL SCREW WAS OBSERVED TO HAVE MISSED THE NAIL POSTERIORLY THOUGH THE BLADE WAS THROUGH THE NAIL. THE BLADE IS PLACED THROUGH THE SAME AIMING ARM AS THE SCREW. IT WAS ALSO OBSERVED THAT THE NAIL HAD CUT OUT OF THE CONDYLES ANTERIORLY WHICH MUST HAVE HAPPENED DURING THE INSERTION OF THE FIRST DISTAL SCREW. THE CONSULTANT WAS CALLED AND ALL DEVICES WERE REMOVED. WHEN THE KNEE WAS OPENED UP THERE WAS A LARGE SPLIT BETWEEN THE CONDYLES. THIS WAS REPAIRED WITH UNKNOWN CANCELLOUS 6.5MM SCREWS AND A COMPETITOR¿S CABLE SYSTEM. THE NAIL AND AIMING ARMS WERE RE-TESTED AND ONCE AGAIN EVERYTHING LINED UP. THE NAIL WAS THEN RE-INSERTED AND LOCKED WITH A DISTAL SCREW, BLADE AND ONE PROXIMAL SCREW. THE SURGERY WAS PROLONGED APPROXIMATELY TWO (2) HOURS DUE TO THE REPORTED EVENT. ALL SCREWS WENT THROUGH THE NAIL AND THE SURGEON WAS SATISFIED WITH FINAL OUTCOME. ALL IMPLANTS WERE IMPLANTED. THE PATIENT¿S POST-OPERATIVE STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: 1X DRILL BIT 13MM (PART AND LOT UNKNOWN); 1X GUIDE WIRE (PART AND LOT UNKNOWN); 1X REDUCTION TOOL (PART AND LOT UNKNOWN); 1X REAMING WIRE (PART AND LOT UNKNOWN); 1X JIG (PART AND LOT UNKNOWN); 1X BLADE (PART AND LOT UNKNOWN); 1X SCREW 5MM (PART AND LOT UNKNOWN); 1X SCREW DISTAL (PART AND LOT UNKNOWN); SCREWS CANCELLOUS 6.5MM (PART, LOT AND QUANTITY UNKNOWN); 1X COMPETITOR CABLE SYSTEM (PART AND LOT UNKNOWN); 1X SCREW PROXIMAL (PART AND LOT UNKNOWN); 1X AIMING ARM (PART 03.010.050 LOT 3697469); 1X INSERTION HANDLE (PART 03.010.046 LOT 3620465); 1X PROTECTION SLEEVE (PART 03.010.065 LOT 3666918). THIS REPORT IS FOR ONE, UNKNOWN EXPERT R/AFN NAIL 13MM X 340MM. THIS IS REPORT 2 OF 2 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52056 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention 03.010.046, PERCUTANEOUS INSERTION HANDLE| 03.010.050, AIMING ARM FOR RETRO STAND LOCKING| 03.010.065, 8.0MM/4.2MM DRILL SLEEVE 200MM| UNKNOWN BLADE, QTY 1| UNKNOWN CANCELLOUS SCREWS 6.5MM, QTY UNKNOWN| UNKNOWN COMPETITOR¿S CABLE SYSTEM| UNKNOWN DISTAL SCREW, QTY 1| UNKNOWN DRILL BIT 13MM, QTY 1| UNKNOWN GUIDE WIRE, QTY 1| UNKNOWN JIG, QTY 1| UNKNOWN PROXIMAL SCREW, QTY 1| UNKNOWN REAMING WIRE, QTY 1| UNKNOWN REDUCTION TOOL, QTY 1| UNKNOWN SCREW 5MM, QTY 1