BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5131575 · Received October 7, 2015

    Report

    Report Number
    2520274-2015-16466
    Event Type
    Injury
    Date Received
    October 7, 2015
    Report Date
    September 14, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR TWO, UNKNOWN 2.4MM CORTEX SCREWS. REPORTED PART NUMBERS ARE AS FOLLOWS: 201.780, QTY 2, 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 30MM, 510(K) K112583, DEVICE PRODUCT CODE--HWC, COMMON NAME¿SCREW, FIXATION, BONE; 201.772, QTY 2, 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM, 510(K) K112583, DEVICE PRODUCT CODE--HWC, COMMON NAME¿SCREW, FIXATION, BONE; 201.770, QTY 1, 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM, 510(K) K112583, DEVICE PRODUCT CODE--HWC, COMMON NAME¿SCREW, FIXATION, BONE; 201.776, QTY 1, 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM, 510(K) K112583, DEVICE PRODUCT CODE--HWC, COMMON NAME¿SCREW, FIXATION, BONE; AND 201.778, QTY 1, 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 28MM, 510(K) K112583, DEVICE PRODUCT CODE--HWC, COMMON NAME¿SCREW, FIXATION, BONE. IT IS UNKNOWN WHICH TWO OF THE ABOVE REPORTED SCREWS HAD BROKEN. (B)(4) ADDITIONAL X-RAYS AND OTHER UNKNOWN TREATMENT TO ADDRESS BROKEN SCREWS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    IT WAS REPORT THAT X-RAYS TAKEN ON (B)(6) 2015 REVEALED TWO BROKEN UNKNOWN 2.4MM SCREWS AT THE FIRST METATARSAL JOINT FUSION (RIGHT SIDE). THE PATIENT INITIALLY WAS IMPLANTED WITH TWO, 2.4MM/2.7MM VARIABLE ANGLE (VA) LOCKING X-PLATES AND NINE SCREWS ON (B)(6) 2014. IT IS UNKNOWN WHICH OF THE REPORTED PLATES IS ASSOCIATED WITH THE BROKEN SCREWS. ANTICIPATED TREATMENT AND ADDITIONAL DETAILS ARE ALSO CURRENTLY UNKNOWN. THIS REPORT IS FOR TWO, UNKNOWN 2.4MM CORTEX SCREWS. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663301 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention