BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER

    MDR report key: 8621210 · Received May 17, 2019

    Report

    Report Number
    2939274-2019-58162
    Event Type
    Injury
    Date Received
    May 17, 2019
    Report Date
    April 19, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982089205
    PMA / PMN Number
    K103002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. DEVICE HISTORY LOT. PART: 04.016.038S. LOT: 9221170. MANUFACTURING SITE: MEZZOVICO. RELEASE TO WAREHOUSE DATE: 17. DEC. 2014 . EXPIRY DATE: 01. DEC. 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. LOT NUMBER PROVIDED FOR REPORTING. 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 · 0

    (B)(6) 2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT HAD HARDWARE REMOVAL DUE TO NON UNION, ONE (1) MULTILOC HUMERAL NAIL, ONE (1) MULTILOC SCREW LENGTH 50MM, ONE (1) MULTILOC SCREW LENGTH 42MM, ONE (1) MULTILOC SCREW LENGTH 48MM, ONE (1) MULTILOC SCREW LENGTH 40MM, ONE (1) TITANIUM LOCKING SCREW LENGTH 34MM, AND ONE (1) TITANIUM LOCKING SCREW LENGTH 36MM DUE TO SHOULDER PAIN AND LIMITED MOBILITY OF HUMERUS. THERE WERE FOUR PART PROXIMAL HUMERUS FRACTURE FIXED WITH THE NAIL BUT THE BONE HAD GONE ON TO DIE. THE SURGEON REMOVE ALL THE IMPLANTS EASILY BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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) 2019, THE PATIENT HAD HARDWARE REMOVAL OF  ONE (1) MULTILOC HUMERAL NAIL, ONE (1) MULTILOC SCREW LENGTH 50MM, ONE (1) MULTILOC SCREW LENGTH 42MM, ONE (1) MULTILOC SCREW LENGTH 48MM, ONE (1) MULTILOC SCREW LENGTH 40MM, ONE (1) TITANIUM LOCKING SCREW LENGTH 34MM, AND  ONE (1) TITANIUM LOCKING SCREW LENGTH 36MM DUE TO SHOULDER PAIN AND LIMITED MOBILITY OF HUMERUS. THERE WERE FOUR PART PROXIMAL HUMERUS FRACTURE FIXED WITH THE NAIL BUT THE BONE HAD GONE ON TO DIE. THE SURGEON REMOVED ALL THE IMPLANTS BECAUSE THE HEAD JUST FELL INTO VARIOUS COLLAPSE AND TAKE THE DEAD BONY FRAGMENTS. INITIAL SURGERY WAS DONE ON (B)(6) 2018. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 9.5MM TI MULTILOC PROXIMAL HUMERAL NAIL. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414138 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER ROD, FIXATION, INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.016.038S 9221170 10886982089205

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention