BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: ASLS

    MDR report key: 19746225 · Received July 15, 2024

    Report

    Report Number
    8030965-2024-08737
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    August 3, 2023
    Manufacturer
    HWC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4 - 510K: THIS REPORT IS FOR AN UNKNOWN ASLS SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 0

    CLINICAL ADVERSE EVENT RECEIVED FOR LEG LENGTH SHORTENING BY 4.1 CM ON THE RIGHT AFTER III° OPEN FRACTURE OF THE RIGHT LOWER LEG. EVENT IS POSSIBLY RELATED TO THE DEVICE AND RELATED TO PROCEDURE. DATE OF EVENT: 03-AUG-2023 DATE OF IMPLANT: (B)(6) 2023 DATE OF REVISION: (B)(6) 2023 DEVICE LOCATION: RIGHT TIBIA. TREATMENT: SURGERY ON (B)(6) 2023 EXTENSIVE IMPLANT REMOVAL ETNPROTECT (300 X 10 MM) AND IMPLANTATION OF EXTENSION INTRAMEDULLARY NAIL (10.7 X 275, 10°, NON-SYNTHES, 10 MM CAP), OSTEOTOMY TIBIA AND FIBULA. THE FOLLOWING TREATMENT/PRODUCTS IMPLANTED/EXPLANTED ARE NOT IDENTIFIED AS SYNTHES PRODUCTS: IE K-WIRE, 2X2.7 MM SCREWS WITH ULS DISTAL TIBIA AND ANGULAR STABLE PLATE FIBULA. DEPUY SYNTHES PRODUCTS USED: QTY 1 PROTECT NAIL, QTY 1 END CAP, QTY 1 DYNAMIC INTERLOCKING SCREW, QTY 3 STATIC ASLS (ANGULAR STABLE LOCKING SYSTEM) SCREWS CATALOG: 04.004.440SAB LOT: N/A COMPONENT TYPE: EXPERT TIBIAL NAIL PROTECT Ø10 CANN L300 DESCRIPTION: CATALOG, LOT AND FURTHER PRODUCT INFORMATION NOT PROVIDED FOR THE SCREWS. OUTCOME IS RECOVERY IN PROGRESS. THIS REPORT IS FOR AN UNKNOWN ANGULAR STABLE LOCKING SYSTEM (ASLS) SCREW. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500897 UNK - SCREWS: ASLS SCREW, FIXATION, BONE HWC HWC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention EXPERT TIBIAL NAIL PROTECT Ø10 CANN L300| UNK - END CAPS| UNK - SCREWS: ASLS| UNK - SCREWS: NAIL DISTAL LOCKING