BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3971834 · Received July 31, 2014

    Report

    Report Number
    2520274-2014-12884
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITERATURE CITATION: FANG ZHOU, MD ET AL : LESS INVASIVE STABILIZATION SYSTEM (LISS) VERSUS PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) IN TREATING PROXIMAL FEMORAL FRACTURES: A PROSPECTIVE RANDOMIZED STUDY AS PUBLISHED IN THE JOURNAL OF ORTHOPAEDIC TRAUMA, VOLUME 26, NUMBER 3, MARCH 2012. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF LISS SCREW WITH AN UNKNOWN PART AND LOT NUMBER. (B)(6). ACUTE CORONARY SYNDROME. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE BY FANG ZHOU, MD ET AL: LESS INVASIVE STABILIZATION SYSTEM (LISS) VERSUS PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) IN TREATING PROXIMAL FEMORAL FRACTURES: A PROSPECTIVE RANDOMIZED STUDY AS PUBLISHED IN THE JOURNAL OF ORTHOPAEDIC TRAUMA, VOLUME 26, NUMBER 3, MARCH 2012. THIS STUDY, PERFORMED BETWEEN (B)(6) 2006 - (B)(6) 2008, INCLUDED 64 CONSECUTIVE PATIENTS WITH PROXIMAL FEMORAL FRACTURES. ALL PATIENTS HAD CLOSED FRACTURES AND WERE TREATED WITHIN 3 WEEKS OF INJURY. EXCLUSION CRITERIA: OPEN FRACTURES, PATHOLOGIC FRACTURES, DELAYED FRACTURES, MULTIPLE FRACTURES, AND PERIPROSTHETIC FRACTURES. THE AMERICAN SOCIETY FOR ANESTHESIOLOGISTS SCORE REGARDING CO-MORBIDITIES AND THE FRACTURE TYPE VARIED ACROSS PATIENTS. THE STUDY POPULATION FOR: LISS (28 PATIENTS): 15 FEMALES AND 13 MALES WITH AVERAGE AGE 67.75, RANGING 24-87 YEARS OLD; PFNA SYSTEM (36 PATIENTS): 19 FEMALES AND 17 MALES WITH AVERAGE AGE OF 76.19, RANGING 42-103 YEARS OLD. FIFTY-NINE OF 64 PATIENTS HAD FOLLOW-UP RESULTS EXCEPT FOR FOUR DEATHS ( 2 FROM PFNA AND 2 FROM LISS) AND 1 LOST TO FOLLOW UP FROM LISS GROUP. SURGERY WAS PERFORMED BY THREE SENIOR SURGEONS. ALL PATIENTS RECEIVED PREOPERATIVE AND POSTOPERATIVE INTRAVENOUS ANTIBIOTICS, CEFUROXIME. SUBCUTANEOUS LOW-MOLECULAR HEPARIN WAS ADMINISTERED FOR 5 DAYS FOR THROMBOEMBOLIC PROPHYLAXIS. PASSIVE AND ACTIVE MOTION OF HIP BEGAN ON THE SECOND DAY AFTER OPERATION. THE TIME OF WEIGHTBEARING DEPENDED ON FOLLOW-UP RADIOGRAPHS. PARTIAL WEIGHTBEARING BEGAN WITH THE APPEARANCE OF FRACTURE HEALING AND TOTAL WEIGHT-BEARING BEGAN WITH CLINICAL FRACTURE HEALING. FOLLOW-UP VISITS OCCURRED AT 1, 3, 6, AND 12 MONTHS AFTER OPERATION AND INCLUDED CLINICAL EXAMINATION, HIP FUNCTION ASSESSMENT, AND RADIOGRAPHS. THE 6-MONTH EVALUATION EXCLUDED PATIENTS WHO REQUIRED REVISION OR HAD DIED. ALL FRACTURES SHOWED UNION WITHIN 6 MONTHS. MEAN FOLLOW-UP TIME WAS 26.8 MONTHS (RANGE, 21¿36 MONTHS). RADIOGRAPHIC IMAGES INCLUDED IN ARTICLE. LISS SURGERY: AN APPROPRIATE-LENGTH DISTAL FEMORAL LISS PLATE WAS CHOSEN USING A RIGHT-SIDED PLATE FOR LEFT FEMUR AND VICE VERSA. SCREWS WERE PLACED IN D, E, AND F HOLES, DISTAL SCREWS WERE INSERTED PERCUTANEOUSLY, THREE OR FOUR SCREWS IN PROXIMAL END OF FRACTURE AND FOUR SCREWS IN DISTAL END ARE REQUIRED. THE PFNA SURGERY WAS PERFORMED WITH A SHAFT ANGLE OF 130 DEGREES AND 12MM DIAMETERS WAS USED IN THE CURRENT STUDY. NAIL WAS INSERTED ACCORDING TO RECOMMENDED MANUFACTURER SURGICAL TECHNIQUE. THIS REPORT IS FOR (B)(4) FOR LISS SCREWS FOR THE FOLLOWING EVENTS: DEEP VEIN THROMBOSIS (3), ACUTE CORONARY SYNDROME (1), AND STROKE (1). A COPY OF JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS 9 OF 10 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446781 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention