BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7299744 · Received February 27, 2018

    Report

    Report Number
    8030965-2018-51442
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 31, 2018
    Report Date
    January 31, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. POSSIBLE PART/LOT INVOLVED: 402.016S LOT. L387887, PART 04.210.114S POSSIBLE LOT. L434616, L215341, L213776 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

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE WAS NOT EXPLANTED 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE FOR A LEFT HALLUX VALGUS DEFORMATION CAUSED BY RHEUMATOID ARTHRITIS ON (B)(6) 2018. DURING THE PROCEDURE, SURGEON FIXED THE FIRST METATARSOPHALANGEAL JOINT USING THE VARIABLE ANGLE (VA) LOCKING X-PLATE AND FOUR (4) LOCKING SCREWS. AFTER APPLYING TORQUE AND INSERTING THE TWO (2) PROXIMAL SCREWS, SURGEON THEN ATTEMPTED TO APPLY TORQUE TO THE TWO (2) DISTAL SCREWS. SURGEON WAS UNABLE TO APPLY PROPER TORQUE TO THESE TWO (2) SCREWS. SURGEON DID CONFIRM THE THREADS ON BOTH THE PLATE HOLES AND THE SCREWS WERE ENGAGED FIRMLY ENOUGH AND COMPLETED THE PROCEDURE WITH THE SCREWS UNLOCKED TO THE PLATE. SURGERY WAS COMPLETED WITH NO DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR TWO (2) UNKNOWN LOCKING SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142488 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1