BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3731200 · Received April 7, 2014

    Report

    Report Number
    2520274-2014-10626
    Event Type
    Injury
    Date Received
    April 7, 2014
    Report Date
    March 12, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. 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. 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 COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    (B)(6). A PRODUCT DEVELOPMENT EVENT EVALUATION WAS COMPLETED: THE RECEIVED PRODUCT SHOWED SEVERE DEFORMATION; ONE SCREW HEAD IS BROKEN. THE FLUOROSCOPY IMAGE ATTACHED TO THE DEVICE REPORT SHOW A COLLAPSED POST-OPERATIVE CONSTRUCT. THE SCREWS THAT WERE IMPLANTED PROXIMALLY TO THE FRACTURE SITE ARE STILL IN CONTACT WITH THE PLATE INTERFACE. HOWEVER THE LOCKING SCREWS DISTALLY TO THE FRACTURE SITE ARE SHOWN AS DISPLACED LATERALLY FROM THE PLATE AND ARE NOT IN DIRECT CONTACT WITH THE PLATE HOLE ANYMORE. THE DISTAL LOCKING SCREWS CAME LOOSE AND WERE PULLED OUT OF THE BONE. ONE DISTAL LOCKING SCREW BROKE IN THE TRANSITION ZONE BETWEEN THE HEAD AND THE SHAFT. MULTIPLE FACTORS CAN LEAD TO THE FAILURE MODE SUCH AS INADEQUATELY TIGHTENED LOCKING SCREWS CAN BECOME LOOSE WHEN A LOAD IS APPLIED BY THE PATIENT. 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 PART/LOT NUMBERS THAT WERE RETURNED ARE 414.056/7749397, 416.070/2791759, 414.042/8486771, 414.046/8076849, 414.054/2696013, 413.440/8633951, 413.440/8548562, 413.440/8728819, 413.485/8508394, 413.485/7673890, 413.485/8583831, 413.485/2807437. SYNTHES CANNOT IDENTIFY WHICH OF THE RETURNED DEVICES ARE THE COMPLAINED DEVICES. 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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR ALL POTENTIAL PART/LOT REPORTED: MANUFACTURING LOCATION: (B)(4): 414.056/ LOT 7749397 MANUFACTURING DATE: JAN 23, 2012; 414.042/ LOT 8486771 MANUFACTURING DATE: JUN 04, 2013; 414.046/ LOT 8076849 MANUFACTURING DATE: SEP 17, 2012. MANUFACTURING LOCATION: (B)(4): 416.070/ LOT 2791759 MANUFACTURING DATE: OCT 04, 2011; 414.054/ LOT 2696013 MANUFACTURING DATE: JAN 31, 2011; 413.440/ LOT 8633951 MANUFACTURING DATE: SEP 23, 2013; 413.440/ LOT 8548562 MANUFACTURING DATE: JUL 30, 2013; 413.475/ LOT 8728819 MANUFACTURING DATE: NOV 25, 2013; 413.485/ LOT 8508394 MANUFACTURING DATE: JUL 01, 2013; 413.485/ LOT 7873890 MANUFACTURING DATE: APR 19, 2012; 413.485/ LOT 8583831 MANUFACTURING DATE: AUG 27, 2013. NO NON-CONFORMANCE REPORTS 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. POTENTIAL PART/LOT NUMBER REPORTED AS 413.475/8728819 SHOULD BE 413.440/8728819. 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

    IT WAS REPORTED THE PATIENT HAD A FRACTURE OF LOWER FEMORAL EPIPHYSIS. AN INTERNAL REVIEW OF THE X-RAYS WAS COMPLETED BY A MEDICAL DIRECTOR: TWO OF THE X-RAYS ARE PRE-OPERATIVE AND SHOW A COMMINUTED FRACTURE OF THE RIGHT DISTAL FEMUR. THIS WAS TREATED WITH A CONDYLAR PLATE AND SCREWS. THREE OF THE POST-OPERATIVE FILMS SHOW THAT THE FOUR DISTAL LOCKING SCREWS SEEM TO BE IN A SATISFACTORY POSITION. TWO OF THE POST-OPERATIVE FILMS SHOW THAT THE FOUR SCREWS HAVE BACKED OUT AND ARE NO LONGER LOCKED INTO THE PLATE. IN ADDITIONAL, THE CLINICAL PICTURE SHOWS THAT ONE OF THE SCREWS HAS PENETRATED THE SKIN AND MORE SCREWS ARE PRESSING AGAINST THE SKIN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN THE IMMEDIATE POST OPERATIVE RADIOGRAPH PROPERLY IMPLANTED SCREWS ARE EVIDENT. IN THE POST OPERATIVE MONITORING OF THE PATIENT, THE SPECIALIST REPORTS THAT THE SCREWS ON THE DISTAL PORTION OF THE PLATE ARE PARTIALLY EXPOSED TO THE OUTSIDE ENVIRONMENT. IT WAS ALSO REPORTED THAT THE PATIENT HAD PAIN AFTER FIRST SURGERY. THERE WAS NO REPORT OF A SURGICAL DELAY. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209329 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention