BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20231046 · Received September 16, 2024

    Report

    Report Number
    8030965-2024-11591
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    September 2, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    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. H11 ADDITIONAL NARRATIVE: DEVICE HISTORY LOT: PART: 03.043.033S. LOT NO:10367007. RELEASE TO WAREHOUSE DATE:15 SEP, 2023. EXPIRY DATE: 01 SEP, 2028. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: GEMÜ GMBH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    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. H11 ADDITIONAL NARRATIVE: B5: ADDITIONAL INFORMATION NOTE IS ADDED IN THE EVENT DESCRIPTION IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. H11 ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. E3: REPORTER IS A J&J SALES REPRESENTATIVE. 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.

    Description of Event or Problem · 0

    THE SURGEON CONFIRMED NO BROKEN PIECES REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT STATUS/OUTCOME WAS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH TNA FOR TIBIA. THE SURGERY WAS PERFORMED WITH A SUPRAPATELLAR APPROACH. THE PROTECTION SLEEVE WAS USED AFTER INSERTING A GUIDE WIRE. THE SURGEON ATTEMPTED TO MAKE AN INCISION IN THE PROXIMAL TIBIA WITH AN ENTRY REAMER. HOWEVER, THE PROTECTION SLEEVE IN QUESTION DENTED DUE TO PRESSURE IN THE JOINT, MADE IT DIFFICULT FOR THE ENTRY REAMER TO PASS THROUGH. THE ENTRY REAMER WAS REMOVED FROM THE JOINT, AND THE ENTRY REAMER WAS PASSED MIDWAY THROUGH THE JOINT. THE PROXIMAL TIBIA WAS OPENED AGAIN. HOWEVER, PRESSURE WAS STRONG, AND METAL IN THE PROTECTION SLEEVE WAS DAMAGED. ANOTHER SLEEVE IN THE INSTRUMENT SET WAS USED FOR COMPLETE THE SURGERY SUCCESSFULLY WITH A 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759716 PROTECTION SLEEVE/ FLEX/ LONG FOR NAILS Ø 8-11MM / STERILE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES GMBH 10367007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown