BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 8299268 · Received February 1, 2019

    Report

    Report Number
    2939274-2019-56271
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Report Date
    January 15, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188373
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: IT HAS BEEN RECEIVED 6 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURES RECEIVED, IT CAN BE OBSERVED A PARTICLE INSIDE THE SYRINGE. DHR OF LOT 1801288 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. SINCE PHYSICAL SAMPLE HAS NOT BEEN RECEIVED, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. IT IS POSSIBLE THAT IF SYRINGE WAS FILLED WITH DRUG FROM A VIAL USING A NEEDLE, THIS PARTICLE COMES FROM THE RUBBER VIAL DUE TO CORING DEFECT (PARTICLE OF RUBBER DETACHED DUE TO NEEDLE PENETRATION). BUT SINCE THE PARTICLE CANNOT BE INSPECTED IT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, (14) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WERE WORN OUT AFTER YEARS OF USE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS A CONTINUATION OF TEN (10) DEVICES ON (B)(4). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92315 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 314.02 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1