BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM

    MDR report key: 8812487 · Received July 22, 2019

    Report

    Report Number
    2939274-2019-59304
    Event Type
    Malfunction
    Date Received
    July 22, 2019
    Date of Event
    June 1, 2019
    Report Date
    June 25, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587011875
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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. AWARENESS DATE REPORTED ON FOLLOW UP 1 REPORT AS (B)(6) 2019 BUT SHOULD HAVE BEEN (B)(6) 2019. 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. ADDITIONAL NARRATIVE: PART # 03.503.071, SYNTHES LOT # U203390, SUPPLIER LOT # U203390, RELEASE TO WAREHOUSE DATE: 27 OCT 2014; 09 DEC 2014, SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE SCREWDRIVER BLADE WAS RECEIVED AT US CQ. NO MATING SCREWS WERE RETURNED WITH THE SCREWDRIVER. THE DISTAL THREADS OF THE SCREWDRIVER ARE TWISTED. THE THREADS WERE TWISTED IN THE DIRECTION OF RESISTANCE FROM INSERTION. THERE ARE LIGHT SURFACE SCRATCHES ALONG THE SHAFT THAT ARE CONSISTENT WITH WEAR. THE DRIVER SHOWED POTENTIAL END OF LIFE INDICATORS AND NORMAL WEAR FROM CONSISTENT/HEAVY USAGE DURING VISUAL INSPECTION. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. VISUAL INSPECTION DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING (4+ YEARS); THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. THE STRIPPED CONDITION OF THE SCREW DRIVERS THREADS MAY LEAD TO DIFFICULTIES WITH ASSEMBLING TO THE ASSOCIATED MATING SCREWS, THUS THE COMPLAINT OF UNABLE TO ASSEMBLE CAN BE CONFIRMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS SYNTHES SALES CONSULTANT. 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

    IT WAS REPORTED THAT ON (B)(6) 2019 DURING HUMERUS OPEN REDUCTION AND INTERNAL FIXATION (ORIF)), THE MATRIXMANDIBLE SELF-RETAINING SCREWDRIVER BLADE TIP WAS BENT AND THE SCREWS WAS NOT RETAINING ANYMORE. WHEN THE EVENT OCCURRED THEY HAVE NEW SCREWDRIVER. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS STABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE/THORAX SCREWDRIVER BLADE SELF RETAINING-MEDIUM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605464 MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.503.071 U203390 10887587011875

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR UNK - SCREWS: TRAUMA| UNK - SCREWS: TRAUMA