BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7131038 · Received December 19, 2017

    Report

    Report Number
    2939274-2017-50378
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    November 21, 2017
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: (B)(6). DATE OF DEVICE BREAKAGE AND NON-UNION IS NOT KNOWN. 510K: THIS REPORT IS FOR TWO (2) UNKNOWN CORTEX SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 1

    DEVICE 4.5 MM CORTEX SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 2) REPORTED INADVERTENTLY AS CONCOMITANT DEVICE; HOWEVER, THESE TWO SCREWS ARE BROKEN REPORTABLE SCREWS. 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 A PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) ON (B)(6) 2017 DUE TO A HUMERAL NON-UNION AND TWO (2) BROKEN 4.5 MM CORTEX SCREWS. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. REMOVED HARDWARE INCLUDED ONE (1) PLATE WITH TWO (2) 4.5 MM CORTEX SCREWS, THREE (3) UNKNOWN 4.5 MM SCREWS AND THREE (3) 5.0 MM LOCKING SCREWS. THE HARDWARE WAS REPORTED TO BE REMOVED EASILY AND WITHOUT INCIDENT AND NO FRAGMENTS WERE RETAINED FROM THE BROKEN SCREWS. THE PATIENT WAS REVISED TO A NEW PLATE AND UNKNOWN QUANTITY OF SCREWS OF THE SAME TYPE. BONE ALLOGRAFT AND AUTOGRAFT WAS USED. THERE WAS NO REPORTED SURGICAL DELAY AND NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTIONS WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 4.5 MM NARROW LOCKING COMPRESSION PLATE (LCP) PLATE (PART 224.591, LOT H181713, QUANTITY 1), 4.5 MM CORTEX SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 2), 4.5 MM SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3), 5.0 MM LOCKING SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908494 SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention