BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG DHS PLATE-STANDARD BARREL 2 HOLES/46MM

    MDR report key: 10628936 · Received October 5, 2020

    Report

    Report Number
    2939274-2020-04488
    Event Type
    Injury
    Date Received
    October 5, 2020
    Report Date
    September 13, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    JDO
    UDI-DI
    10886982176462
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. H10: ADDITIONAL NARRATIVE: D10 H3, H4, H6: PART 281.021, LOT L940669: MANUFACTURING SITE: GRENCHEN. RELEASE TO WAREHOUSE DATE: JULY 20, 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: UPON VISUAL INSPECTION, IT IS OBSERVED THAT THERE WERE FEW SCRATCHES ALL OVER THE BODY. FEW MINOR DENTS WERE OBSERVED NEAR THE SCREW HOLES. THE RELEVANT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION; NO DESIGN ISSUES OR DISCREPANCIES WERE NOTED DURING THE INVESTIGATION. THE COMPLAINT CONDITION WAS BEING CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED PROBLEM COULD NOT BE DETERMINED. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN/MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    ADDITIONAL PRODUCT CODE KTT. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. INITIAL REPORTER PHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PROXIMAL FEMUR FRACTURE LOSS OF REDUCTION WITH DYNAMIC HIP SCREW SYSTEM (DHS) + CANNULATED SCREW AND WAS REVISED TO TOTAL HIP. THE PROCEDURE OUTCOME AND PATIENT'S STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094525 130 DEG DHS PLATE-STANDARD BARREL 2 HOLES/46MM APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR JDO WRIGHTS LANE SYNTHES USA PRODUCTS LLC 281.021 L940669 10886982176462

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention