BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/300MM-STERILE

    MDR report key: 6877331 · Received September 19, 2017

    Report

    Report Number
    1719045-2017-10943
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    August 28, 2017
    Report Date
    August 29, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN, THIS EVENT HAS BEEN REVIEWED BY THE CQ CCHART TEAM AND WILL BE REPORTED AS A PATIENT DEATH WITHOUT PRODUCT MALFUNCTION. (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES: THERAPY DATES: (B)(6) 2017. 3.2MM GUIDE WIRE 290MM(ITEM NUMBER 03.010.115, LOT NUMBER UNKNOWN, QUANTITY 1 EACH), 3.0MM CANNULATED DRILL BIT 300MM (ITEM NUMBER 351.27, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) , 2.5MM REAMING ROD WITH BALL TIP/ 950MM -STERILE (ITEM NUMBER 351.706S, LOT NUMBER UNKNOWN, QUANTITY 1 EACH). THE INFORMATION IN THIS COMPLAINT RECORD REASONABLY SUGGESTS THAT THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE AND THERE IS NO REPORTED MALFUNCTION, HOWEVER THE PATIENT WAS HAVING SURGERY RELATED TO THE DEVICE IN WHICH PATIENT SUBSEQUENTLY EXPIRED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 05-MAR-2015, EXPIRATION DATE: 31-JAN-2024, PART #: 04.013.440S, LOT#: 7931661 (STERILE) - 10MM TI CANNULATED RETRO/ANTEGRADE FEMORAL NAIL-EX/300MM - STERILE. QUANTITY 6. COMPONENT PARTS REVIEWED: PART 21012 - RAW MATERIAL LOT BP-80 LOT - 7860296. RAW MATERIAL RECEIVED FROM DYNAMET INCORPORATED. TITANIUM PRODUCT CERTIFICATION RECEIVED FROM DYNAMET MEET SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MEET REQUIREMENTS. INSPECTION SHEET FOR IN-PROCESS/INSPECT DIMENSIONAL/FINAL (B)(4)REV: J MET INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. ¿STERILITY DOCUMENTATION WAS REVIEWED AND DETERMINED TO BE CONFORMING.¿ 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

    (DEATH COMPLAINT) IT WAS REPORTED THAT A RETROGRADE NAIL WAS TEMPORARILY IMPLANTED AND THEN EXPLANTED DURING A FEMUR FRACTURE REPAIR PROCEDURE ON (B)(6) 2017. THE TYPE OF FRACTURE THAT THE PATIENT PRESENT WITH WAS A PERI-PROSTHETIC DISTAL FEMUR FRACTURE. THERE WAS NO MORE THAT A WEEK FROM TIME OF INJURY TO THE DATE OF SURGERY. THE PROCEDURE WAS PLANNED AS A RETROGRADE NAIL VERSES TOTAL DISTAL FEMUR REPLACEMENT. WHEN THE PROCEDURE WAS UNDERWAY, WHILE ATTEMPTING TO IMPLANT THE RETROGRADE NAIL, THE SURGEON HAD TO CREATE A LARGER INCISION TO HELP REDUCE THE FRACTURE. SURGEON THEN DECIDED TO REMOVE THAT NAIL AND PROCEED WITH A DISTAL FEMORAL REPLACEMENT. THERE WAS NO REPORTED MALFUNCTION WITH THE RETROGRADE NAIL. PATIENT WAS REPORTED AS AN ELDERLY FEMALE WITH NOTED HAVING QUALITY OF BONE ISSUES. THERE WAS A TWENTY MINUTE SURGICAL DELAY AS THE SURGEON EXPLANTED THE RETROGRADE NAIL. INTER-OPERATIVE,THE PATIENT BEGAN SHOW SIGNS OF DISTRESS AND ANESTHESIA INTERVENED. DUE TO THE PATIENT PRESENTING WITH SIGNS OF DISTRESS SURGEON WAS PLANNING TO POSTPONE THAT SURGERY, AND RESCHEDULED AT A LATER DATE. AT THIS POINT IN THE PROCEDURE, SALES CONSULTANT LEFT THE OPERATING ROOM. ALL IMPLANTS WERE REMOVED FROM THE PATIENT. THE SALES CONSULTANT LATER BECAME AWARE THAT THE PATIENT SUBSEQUENTLY EXPIRED. SALES CONSULTANT IS UNAWARE OF THE TIME AND CAUSE OF THE PATIENTS DEATH. THIS REPORT IS FOR ONE (1) DEVICE. CONCOMITANT DEVICES: 3.2MM GUIDE WIRE 290MM(ITEM NUMBER 03.010.115, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) 3.0MM CANNULATED DRILL BIT 300MM (ITEM NUMBER 351.27, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) 2.5MM REAMING ROD WITH BALL TIP/ 950MM -STERILE (ITEM NUMBER 351.706S, LOT NUMBER UNKNOWN, QUANTITY 1 EACH). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656434 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/300MM-STERILE ROD,FIXATION,INTRAMEDULLARY JDS SYNTHES MONUMENT 7931661

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death