BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 6615067 · Received June 6, 2017

    Report

    Report Number
    2520274-2017-11771
    Event Type
    Injury
    Date Received
    June 6, 2017
    Report Date
    May 9, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEVICE BREAKAGE IS NOT KNOWN 510K: THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. FOUR (4) POSSIBLE PART AND LOT NUMBERS REPORTED, IT IS NOT KNOWN IF ANY OF THE FOUR ARE CORRECT. POSSIBLE PART AND LOT: 04.211.020S LOT L173116, 04.211.020S LOT L219977, 04.211.026S LOT L147835, 04.211.026 LOT 9815064. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICE THERAPY DATE IS NOT KNOWN. (B)(6). 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE TO REPAIR HALLUX VALGUS ON (B)(6) 2017. A SPLINT FIXATION WAS DONE POST-OPERATIVELY AND THE PATIENT BEGAN REHABILITATION WITH PARTIAL WEIGHT BEARING. PATIENT WAS DUE TO BE DISCHARGED ON (B)(6) 2017 UNTIL AN X-RAY TAKEN ON (B)(6) 2017 REVEALED A LOCKING SCREW WAS BROKEN. NO REMOVAL PROCEDURE IS PLANNED. SURGEON INSTEAD OPTED TO SWITCH THE SPLINT FIXATION TO THE SOLE PLATE FIXATION. NO DELAY IN PROCEDURE WAS REPORTED. PATIENT STATUS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: 2.4/2.7MM VARIABLE ANGLE (VA) LOCKING OPENING WEDGE PLATE (PART 04.211.214S, LOT 7856771, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395871 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention