BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - EXTRACTION INSTRUMENTS: TRAUMA

    MDR report key: 12845441 · Received November 19, 2021

    Report

    Report Number
    8030965-2021-09664
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    October 26, 2021
    Report Date
    October 26, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. DEVICE HISTORY LOT - PART: 413.360S, LOT: L150032, MANUFACTURING SITE: GRENCHEN, SUPPLIER: N/A, RELEASE TO WAREHOUSE DATE: 06 OCTOBER 2016, EXPIRATION DATE: 01 SEPTEMBER 2026. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN EXTRACTION INSTRUMENT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR THE DISTAL FEMORAL FRACTURE WITH THE LOCKING COMPRESSION-DISTAL FEMUR (LCP-DF) PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL SURGERY OF THE LCP-DF PLATE FOR THE TOTAL KNEE ARTHROPLASTY (TKA) SURGERY. DURING THE REMOVAL SURGERY, THE SURGEON COULD NOT REMOVE THE FOUR DISTAL LOCKING SCREWS BY USING THE DRIVER, BECAUSE DISTAL LOCKING SCREWS WERE FIRMLY FIXED TO THE PLATE. THE SURGEON COULD REMOVE ONE OF THE FOUR DISTAL LOCKING SCREW BY USING THE EXTRACTION SCREW. HOWEVER, WHEN THE SURGEON TRIED TO REMOVE TWO OF FOUR DISTAL LOCKING SCREW, THE EXTRACTION SCREW BROKE IN THE SCREWHEAD. THE FRAGMENT WAS REMAINED IN THE SCREWHEAD. THE SURGEON TRIED TO REMOVE THEM BY USING A CARBIDE DRILL, AND HE COULD FINALLY REMOVE THE PLATE BY DIGGING THE PLATE NEAR THE DISTAL LOCKING SCREW WHICH WAS DIFFICULT TO REMOVE. THE SURGEON SUCCESSFULLY REMOVED THE SCREW SHAFT USING A RADIO PINCER AND A FORCEPS FOR SCREW REMOVAL. FOR THE FOURTH LOCKING SCREW, THE SURGEON DRILLED THE HEAD OF THE SCREW BY USING A CARBIDE DRILL. THE SURGEON SUCCEEDED IN REMOVING ALL IMPLANTS, BUT THE METAL POWDER GENERATED DURING EXCAVATION ADHERED TO THE SOFT PARTS, SO THE SURGEON CLEANED, AND TRIED TO REMOVE THEM, BUT COULD NOT REMOVE THEM COMPLETELY. THEY WERE REMAINED IN THE PATIENT'S BODY. THE SURGERY WAS DELAYED BY NINETY (90) MINUTES AND COMPLETED SUCCESSFULLY. THE TKA SURGERY WILL BE PERFORMED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN EXTRACTION INSTRUMENT. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743239 UNK - EXTRACTION INSTRUMENTS: TRAUMA EXTRACTOR HWB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Female LCP-DF 4.5/5 R 5HO L156 TAN| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING| UNK - SCREWS: NAIL DISTAL LOCKING