BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 8655073 · Received May 30, 2019

    Report

    Report Number
    2939274-2019-58388
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Report Date
    May 1, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013305
    PMA / PMN Number
    K082649
    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. THE HANDPIECE FOR 90-DEGREE SCREWDRIVER (PART # 03.505.004, LOT # 8140696, MFG # 15-MAY-2014) WAS RECEIVED WITH THE DISTAL THREADS STRIPPED. THIS IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION, THUS CONFIRMING THE COMPLAINT. A DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE COMPLAINT WAS ABLE TO BE VISUALLY CONFIRMED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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 HISTORY LOT: PART: 03.505.004. LOT: 8140696. MANUFACTURING SITE: SELZACH. SUPPLIER: DIENER AG PRECISION MACHINING. RELEASE TO WAREHOUSE DATE: 15. MAY 2014. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 DEVICE PRODUCT CODES: DZJ, HXX. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 AN UNKNOWN DATE, THREADS ON 90 DEGREE DRILL HANDPIECE ARE STRIPPED, THE SHAFT FOR 90-DEGREE DRIVER WOULD NOT THREAD ON. IT DID THREAD ONTO A DIFFERENT HANDPIECE THOUGH. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER SHAFT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1). THIS REPORT IS FOR ONE (1) HANDLE FOR 90 DEGREE SCREWDRIVER.. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447814 HANDLE FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.004 8140696 10887587013305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWDRIVERS: SHAFTS