BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDHS®/DCS® LAG SCREW 14.0MM THREAD/80MM-STERILE

    MDR report key: 9638189 · Received January 28, 2020

    Report

    Report Number
    8030965-2020-00689
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Report Date
    January 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. H3, H4, H6: PART 02.224.222S, LOT 9130862: MANUFACTURING SITE: GRENCHEN. RELEASE TO WAREHOUSE DATE: OCTOBER 01, 2014. EXPIRY DATE: SEPTEMBER 01, 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE RECEIVED LCP DHS-PLATE 135° WAS FOUND IN GOOD CONDITION. A VISUAL INSPECTION WAS PERFORMED, AND NO DAMAGE COULD BE DETECTED. A FUNCTIONAL CHECK WAS PERFORMED WITH AN AVAILABLE DHS SCREW. IT WAS POSSIBLE TO INSERT THE SCREW INTO THE PLATE WITHOUT ANY PROBLEMS. THEREFORE, WE CAN CONFIRM THAT THE INSTRUMENT DOES WORK AS INTENDED. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RECEIVED PLATE IS ALL IN ALL IN GOOD CONDITION AND NO DAMAGE COULD BE DETECTED. THE COMPLAINED MALFUNCTION IS NOT RELATED TO THE LCP DHS-PLATE, THEREFORE THE COMPLAINT IS UNCONFIRMED. THIS LOT WAS MANUFACTURED IN OCTOBER 2014 ACCORDING TO THE SPECIFICATION. THE REVIEW OF THE PRODUCTION HISTORY REVEALED THAT THIS LCP DHS-PLATE WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. NO COMPLAINT RELATED ISSUES WERE FOUND. AS THE FUNCTIONAL TEST HAS SHOWN NO DEVIATIONS OR MALFUNCTIONS AT THE COMPLAINED IMPLANT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H11: G1. G5: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 510K NUMBER K791619 REPORTED IN ERROR. B4/G4: AWARENESS DATE ORIGINALLY REPORTED AS JANUARY 08, 2020 BUT SHOULD HAVE BEEN JANUARY 07, 2020. 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 · 1

    ADDITIONAL PRODUCT CODE: JDO. REPORTER IS A SYNTHES EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 REPORTED ON AN UNKNOWN DATE THAT THE PLATE DOES NO FIT INTO THE SCREW. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102360 LDHS®/DCS® LAG SCREW 14.0MM THREAD/80MM-STERILE APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9130862

    Patients

    Seq Age Sex Outcome Treatment
    1