BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM CANNULATED CONICAL SCREW 50MM

    MDR report key: 8723879 · Received June 21, 2019

    Report

    Report Number
    8030965-2019-65558
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Report Date
    May 26, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL PRODUCT CODES: HTY, JDW, HRS. PART 02.205.250, LOT H543792: MANUFACTURING DATE: JANUARY 23, 2018. MANUFACTURING LOCATION: MONUMENT. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS COMPLETED: THE SCREW WAS RECEIVED WITH PORTIONS OF THE THREADS ON THE SHAFT STRIPPED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED SCREW. DIMENSIONAL INSPECTION SHOWED THE RELEVANT DIMENSIONS WERE CONFORMING. THE RELEVANT DRAWINGS, REFLECTING THE MANUFACTURED AND CURRENT REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. IT IS POSSIBLE THAT STRIPPED CONDITION WAS DUE TO EXCESSIVE FORCES/TORQUE APPLIED DURING INSERTION OR EXTRACTION. DURING THIS INVESTIGATION NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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

    DURING INVESTIGATION OF THE RETURNED DEVICES IT WAS NOTED THAT PORTIONS OF THE THREADS ON THE SHAFT OF THE SCREW WERE STRIPPED. CONCOMITANT DEVICES: CORTEX SCREW (PART 214.838, LOT 9202997, 9271477, L888929, QUANTITY 3); CORTEX SCREW (PART 214.840, LOT L663008, QUANTITY 1); LOCKING SCREW (PART 212.212, LOT 9201970, QUANTITY 1); SCREW (PART/LOT UNKNOWN, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. NO FACILITY CONTACT AVAILABLE; INITIAL REPORTER IS 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 REPORTED ON AN UNKNOWN DATE, A REVISION SURGERY WAS SCHEDULED DUE TO A POSSIBLE REFRACTURE AND OR NON-UNION. THE CONSTRUCT ORIGINALLY IMPLANTED WAS IMPLANTED OFF-LABEL. THE REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2019 AND WILL BE PERFORMED BY ANOTHER SURGEON. ORIGINAL IMPLANT DATE WAS ON (B)(6) 2019. IT IS UNKNOWN IF THE RE-SCHEDULED SURGERY HAS OCCURRED. (B)(4). THIS REPORT IS FOR UNKNOWN SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518249 5.0MM CANNULATED CONICAL SCREW 50MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH H543792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORTSCR Ø4.5 SELF-TAP L38 SST| CORTSCR Ø4.5 SELF-TAP L38 SST| CORTSCR Ø4.5 SELF-TAP L38 SST| CORTSCR Ø4.5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L36 SST| UNK - SCREWS: TRAUMA