BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 7903890 · Received September 24, 2018

    Report

    Report Number
    2939274-2018-53927
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Report Date
    August 30, 2018
    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
    ID, US
    Reporter Occupation
    OTHER

    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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 03.505.004, LOT: 8172621. MANUFACTURING LOCATION: SELZACH, MANUFACTURING DATE: JUN 09, 2017.THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. THE HANDLE FOR THE 90-DEGREE SCREWDRIVER WAS RECEIVED INTACT WITH NO OBSERVED DEFECTS. THE HANDLE WAS ASSEMBLED WITH THE FOLLOWING RETURNED MATING PARTS: TURNING HANDLE 03.505.005/LOT 8165481/QUANTITY 1; SHAFT 03.505.003/LOT 8172030/QUANTITY 2. THE HANDLE COULD BE ASSEMBLED WITH EVERY COMBINATION OF PARTS RETURNED; WHEN ASSEMBLED WITH EITHER RETURNED SHAFT AND ONE TURNING HANDLE, THE GEARS OF THE SHAFTS WERE ABLE TO BE ROTATED AS INTENDED. NO FUNCTIONAL ISSUES WERE NOTED WITH THE ANY RETURNED PART. THE DEVICE IS ALSO INTENDED TO DISASSEMBLE FOR STERILIZATION AND WAS FOUND TO FULLY ASSEMBLE AND DISASSEMBLE AS INTENDED. IT WAS DETERMINED THAT THE RECEIVED CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION FOR THIS DEVICE ¿ THE COMPLAINT CANNOT BE REPLICATED WITH THE RETURNED DEVICE AND THE COMPLAINT WAS NOT CONFIRMED. THE COMPLAINT CONDITION IS UNCONFIRMED AS THE DEVICE FUNCTIONED AS INTENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS THE CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN AND THE COMPLAINT CONDITION COULD NOT BE REPLICATED. NO DESIGN OR MANUFACTURING DEFECT OR DEFICIENCY WAS OBSERVED DURING THE INVESTIGATION. 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 · 1

    DATE OF EVENT: UNKNOWN. ADDITIONAL DEVICE PRODUCT CODES: DZJ, HXX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPORTER IS SYNTHES SALES CONSULTANT. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. 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 DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE SURGEON USED THE MATRIXRIB SET TO FIX SEVERAL RIB FRACTURES. DURING THE CASE, THE SURGEON ELECTED TO USE THE 90-DEGREE PERCUTANEOUS DRIVER SET. THESE WERE THE PARTS USED FROM THE SET; ONE (1) TURNING HANDLE FOR SCREWDRIVER, TWO (2) HANDLE FOR SCREWDRIVER AND TWO (2) SHAFT FOR SCREWDRIVER. THE 90-DEGREE DRIVERS AND SHAFTS WERE ACTING LIKE THEY WERE STRIPPED OUT. ONE DRIVER WAS STILL WORKING DECENTLY. IT WAS NOTED ALSO THAT THE SURGEON INDICATED THAT THE KNOB WAS TURNING ON THE 90-DEGREE SCREWDRIVER, BUT THE CRUCIFORM TIP WAS NOT. AN UNKNOWN SCREWS WERE INVOLVED IN THE PROCEDURE BUT HAD NO ALLEGATION. THE DRIVER WAS VISUALIZED AS THE SURGEON WAS PUTTING IN THE SCREW AND IT WAS STILL IN CONTACT WITH THE SCREW HEAD. THERE WAS AN ISSUE WITH THE DRIVER MECHANISM. THE SCREWDRIVER HAD ISSUES ON SEVERAL SCREWS DURING THIS CASE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT HARM REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) HANDLE FOR 90° SCREWDRIVER. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743145 HANDLE FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.004 8172621 10887587013305

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR