BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.3MM THREADED LCP(TM) DRILL GUIDE

    MDR report key: 8069253 · Received November 14, 2018

    Report

    Report Number
    8030965-2018-58198
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Report Date
    October 29, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819246607
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 323.042. LOT: 7772301. MANUFACTURING SITE: BETTLACH. RELEASE TO WAREHOUSE DATE: 02.APR.2012. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H6: THE COMPLAINT COULD BE CONFIRMED DUE TO THE RECEIVED PICTURES. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. 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 DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THAT SEVEN (7) LOCKING COMPRESSION PLATE (LCP) DRILL SLEEVES WERE NOTICED TO BE OF LOWER QUALITY; THE PREVIOUS OPERATING CYCLE WAS LONGER, AND THE DRILL SLEEVES WORE OUT LIKE THREAD CUTTING. THE LCP DRILL SLEEVES BEGAN TO CRUMBLE INTO THE THREADED PART. THERE IS NO PROCEDURE AND PATIENT INVOLVED. THIS REPORT IS FOR A 4.3MM THREADED LCP(TM) DRILL GUIDE. THIS IS REPORT 5 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912199 4.3MM THREADED LCP(TM) DRILL GUIDE GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 7772301 07611819246607

    Patients

    Seq Age Sex Outcome Treatment
    1