BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - NAIL INSERTION HANDLES

    MDR report key: 9807058 · Received March 9, 2020

    Report

    Report Number
    8030965-2020-01748
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 25, 2020
    Report Date
    February 25, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 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

    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. H6: THE RECEIVED PICTURE WAS REVIEWED AND IT IS VISIBLE THAT THE LAG SCREW DID MISS THE TFNA NAIL AS COMPLAINED. THE INVOLVED INSTRUMENTS ARE NOT VISIBLE ON THE RECEIVED X-RAY AND IT IS NOT POSSIBLE TO DEFINE IF OR WHAT ROLE THEY DID PLAY IN THIS CASE. THEREFORE IS THE COMPLAINT RATED AS N/A IN THE CONFIRMED FIELD FOR THE INSTRUMENTS. IN GENERAL WE WOULD LIKE TO POINT OUT FOLLOWING POINTS THAT ARE POSSIBLY RELATED TO THIS COMPLAINT FROM THE TFNA SURGICAL TECHNIQUE DSEM/TRM/0514/0052 103332-181129 DSEM 12/18. PAGE 21 SECTION: 1. ASSEMBLE INSERTION INSTRUMENTS. PRECAUTIONS: ENSURE THAT THE CONNECTION BETWEEN THE NAIL AND THE INSERTION HANDLE IS TIGHT (RETIGHTEN IF NECESSARY) PAGE 24 SECTION: 3. INSERT NAIL WITH HAMMER (OPTIONAL). PRECAUTION: CONFIRM THAT THE NAIL IS TIGHTLY CONNECTED TO THE INSERTION HANDLE, AS HAMMERING MAY LOOSEN THE CONNECTION. PAGE 32 SECTION: 5. INSERT GUIDE WIRE FOR HELICAL BLADE/SCREW. CONFIRM GUIDE WIRE PLACEMENT, IN BOTH PLANES, USING THE IMAGE INTENSIFIER. PRODUCT WAS NOT RETURNED, PART- AND LOT NUMBER WERE NOT PROVIDED, THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE. 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

    CONCOMITANT DEVICES REPORTED: HAMMER/MALLET (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); TFNA LAG SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); TFNA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1);CONNECTING/COUPLING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN INSERTION HANDLE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: COMPANY REPRESENTATIVE. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTING DURING A PROXIMAL FEMORAL FRACTURE PROCEDURE ON (B)(6) 2020, THE LAG SCREW MISSED THE NAIL. IT WAS NOTED THE SCREW ON THE INSERTION HANDLE MAY NOT HAVE TIGHTENED PROPERLY ONTO THE NAIL AND THAT COULD HAVE CAUSED THE BOLT TO BECOME LOOSE DURING THE IMPACTING OF THE NAIL. THE CASE WAS FINISHED SUCCESSFULLY WITH AN HOUR DELAY. THE SURGEON TRIED TO RE-ATTACH THE INSERTION DEVICE BACK ON THE NAIL WHICH DIDN¿T WORK. THE SURGEON FREE HANDED THE SITE AND DRILL AND MANAGED TO GET THE LAG SCREW IN THE NAIL MANUALLY. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN INSERTION HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270089 UNK - NAIL INSERTION HANDLES MISC ORTHO SURGICAL INSTR LXH OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK - NAILS: TFNA| UNK - SCREWS: LAG| UNK-CONNECTING/COUPLING SCREW| UNK-HAMMER/MALLET