BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6700211 · Received July 11, 2017

    Report

    Report Number
    2520274-2017-11921
    Event Type
    Injury
    Date Received
    July 11, 2017
    Report Date
    June 13, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR FOUR UNKNOWN SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IT WAS REPORTED THAT BOTH CORTEX AND VARIABLE ANGLE LOCKING SCREWS WERE IMPLANTED; IT IS UNKNOWN WHICH TYPE OF SCREWS THE FOUR BROKEN ONES WERE. (THERAPY DATE): EXACT DATE UNKNOWN; REPORTED AS APPROXIMATELY 1 YEAR BEFORE EXPLANT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 THAT THE PATIENT EXPERIENCED NONUNION OF THE RIGHT DISTAL TIBIA AND UNDERWENT REMOVAL OF A DISTAL TIBIAL PLATE AND BROKEN SCREWS ON (B)(6) 2017. THE INITIAL SURGERY WAS APPROXIMATELY ONE YEAR AGO. X-RAYS TAKEN POST OPERATIVELY AFTER THE ORIGINAL SURGERY ON UNKNOWN DATE REVEALED THAT FOUR (4) SCREWS WERE BROKEN. DURING THE REVISION SURGERY THREE (3) BROKEN SCREWS WERE REMOVED WITH DIFFICULTY AND A SMALL PIECE OF ONE (1) BROKEN SCREW WAS RETAINED IN PATIENT'S BODY AND THE OTHER SEVEN (7) SCREWS AND ONE (1) PLATE WERE REMOVED INTACT. A TIBIAL NAIL WAS INSERTED. THERE WAS FIFTEEN (15) MINUTES DELAY IN SURGERY DUE TO THE DIFFICULTY IN REMOVING BROKEN HARDWARE. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. ALL HARDWARE WAS REMOVED EXCEPT ONE SMALL PIECE OF SCREW THAT WAS LEFT IN. SCREWS IN THE SHAFT WERE CORTEX SCREWS AND SCREWS DISTALLY WERE VARIABLE ANGLE LOCKING SCREWS. CONCOMITANT DEVICES REPORTED: 2.7/3.5MM VA-LCP MEDIAL DISTAL TIBIA PLATE/8 HOLES/RIGHT (PART 02.118.006, LOT 973245, QUANTITY 1), SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 7). THIS REPORT IS FOR FOUR UNKNOWN SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480463 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention 7 UNKNOWN SCREWS| PART 02.118.006, LOT 973245, DISTAL TIBIA PLATE