BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE

    MDR report key: 17481676 · Received August 8, 2023

    Report

    Report Number
    8030965-2023-09990
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 23, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982298850
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10 ADDITIONAL NARRATIVE: D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. E3: INITIAL REPORTER IS A SYNTHES EMPLOYEE. H3, H6: 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT CODE: 03.043.033S LOT NUMBER: 10297952 RELEASE TO WAREHOUSE DATE: 25.JAN.2022 EXPIRATION DATE: 01.JAN.2027 SUPPLIER: GEMÜ GMBH MANUFACTURING SITE: WERK SELZACH 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

    DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY WITH PROTECTION SLEEVE, TROCAR AND TNA NAIL. AFTER INSERTING THE PROTECTION SLEEVE THE TROCAR BECAME STUCK. THE SURGEON STOPPED USING THE PROTECTION SLEEVE AND USED THE ETN SLEEVE TO COMPLETE THE PROCEDURE. ADDITIONALLY, WHILE USING A 9MM TNA NAIL, THE DRILL BIT AND NAIL INTERFERED WHEN DRILLING A LATERAL LOCKING DRILL IN THE PROXIMAL ML DIRECTION OVER THE DEVICE. THE OPERATION WAS COMPLETED WITH A FREEHAND DRILL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968175 PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 10297952 10886982298850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown TROCAR F/NAILS Ø8-11 LONG| UNK - DRILL BITS: TRAUMA| UNK - NAILS