BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4559473 · Received March 2, 2015

    Report

    Report Number
    2520274-2015-11343
    Event Type
    Injury
    Date Received
    March 2, 2015
    Date of Event
    February 16, 2015
    Report Date
    February 19, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR TWO UNKNOWN SCREWS. A LIST OF IMPLANTED SCREWS WAS PROVIDED TO SYNTHES; HOWEVER, IT IS UNKNOWN WHICH OF THESE TWO SCREWS BACKED OUT. THE IMPLANTED PART NUMBERS ARE AS FOLLOWS: PART #02.231.244¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/44MM02.1; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.238¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/38MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.240¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/40MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.242¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/42MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.285¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/85MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #214.822¿4.5MM CORTEX SCREW SELF-TAPPING 22MM; 510(K) K112583. PRODUCT DEVICE CODE-HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.280¿5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/80MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. PART #02.231.270 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/70MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. (B)(4) PART #02.131.275 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF TPNG/STRDRV/75MM; 510(K) K110354. DEVICE PRODUCT CODES-JDP, HRS, HWC. COMMON NAME- SCREW, FIXATION, BONE. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE UNKNOWN SCREW/UNKNOWN LOT NUMBER. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 AUSTRIA AS FOLLOWS: IT WAS REPORTED THAT THE USE OF THE VA CONDYLAR PLATE FOR A DISTAL FEMORAL OSTEOTOMY. IT WAS ALSO REPORTED THAT THE SURGEON STATED THAT HE WOULD HAVE TORQUED OFF THE SCREWS AS PRODUCT SPECIALIST WAS IN ATTENDANCE, THE SCREWS BACKED OUT - SURGEON NOT CONFIDENT IN THE LOCKING MECHANISM AS HE NEVER HAD THIS ISSUE WITH THE FIXED ANGLE SCREWS FROM THE LISS SYSTEM. ADDITIONAL PROCEDURE WAS REQUIRED TO REMOVE THE LOOSE SCREWS. DATE OF IMPLANTATION OF VA CONDYLAR SCREW: (B)(6) 2014. DATE IMPLANT REMOVED: (B)(6) 2015. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141815 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention