BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18318517 · Received December 13, 2023

    Report

    Report Number
    8030965-2023-15639
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 20, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    UDI-DI
    10886982298850
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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-CONFORMANCE'S WERE IDENTIFIED. PART# 03.043.033S; LOT # 10351997; MANUFACTURING SITE: WERK SELZACH LOGISTIK; SUPPLIER: GEMÜ GMBH; RELEASE TO WAREHOUSE DATE: 28 JUN 2023; EXPIRATION DATE: 29 FEB 2028. 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

    IT WAS REPORTED THAT ON (B)(6) 2023 DURING AN UNKNOWN PROCEDURE, THE INNER SLEEVE WAS DETACHED FROM THE PROTECTION SLEEVE AND WENT OVER THE PROXIMAL LOCKING HOLES IN THE TIBIAL NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 10 MINUTES OF SURGICAL DELAY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. 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 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269565 PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 10351997 10886982298850

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK - NAILS: TIBIAL