BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 10897324 · Received November 24, 2020

    Report

    Report Number
    2939274-2020-05300
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Report Date
    October 29, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587013299
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. H3, H6: PART: 03.505.003. LOT: 8190939. MANUFACTURING SITE: (B)(4). SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 11.JUL.2019. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SHAFT COMPLETE (P/N: 03.505.003 & LOT NUMBER: 8176222) WAS RECEIVED AT US CUSTOMER QUALITY (CQ) IN DISASSEMBLED CONDITION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED NO DAMAGE TO THE DEVICE EXCEPT MINIMAL WEAR WHICH WOULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. FUNCTIONAL TEST: THE COMPLETE FUNCTIONAL TEST CANNOT BE PERFORMED AS ALL THE MATING DEVICES WERE NOT RETURNED. THE COMPLIANT DEVICE WAS ABLE TO BE ASSEMBLED WITH ALL RETURNED SUBCOMPONENTS AS INTENDED. THE SHAFT COMPLETE (COMPLAINT DEVICE) WAS NOT ABLE TO BE ASSEMBLED COMPLETELY WITH THE MATING DEVICE (SCREWDRIVER HANDLE; PART CODE: 03.505.004 & LOT NO: 8154010) DUE TO THE STRIPPED DISTAL THREADS ON THE MATING DEVICE. THE ALLEGED FUNCTIONAL ISSUE MAY BE CAUSED DUE TO THE DAMAGED MATING DEVICE. CAN COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE(S): UNABLE TO PERFORM DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS NOT PERFORMED AS NO DEFECTS WERE OBSERVED ON THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. THE ALLEGED FUNCTIONAL ISSUE MAY BE DUE TO THE DAMAGED MATING DEVICE, INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS NOT CONFIRMED FOR THE RECEIVED DEVICE AS NO VISUAL DAMAGES WERE OBSERVED ON THE DEVICE THAT WOULD CONTRIBUTE TO THE ALLEGED FUNCTIONAL ISSUE. THE ALLEGED FUNCTIONAL ISSUE MAY BE CAUSED DUE TO THE DAMAGED MATING DEVICE. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED BASED ON THE PROVIDED INFORMATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    REPORTER IS JNJ REPRESENTATIVE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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 · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ASSEMBLY IN STERILIZATION PROCESSING DEPARTMENT (SPD) TO CHECK FOR GOOD OPERATION, THE 90-DEGREE SCREWDRIVER SHAFT AND 90-DEGREE SCREWDRIVER HANDLE WERE SLIPPING AND WILL NOT ADVANCE THE SCREW. THE 90-DEGREE SCREWDRIVER T-HANDLE WAS BROKEN AND TWO LITTLE METALS PIECES AT END ONE IS MISSING CAUSING THE DEVICE TO MALFUNCTION. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357653 SHAFT FOR 90 SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.003 8190939 10887587013299

    Patients

    Seq Age Sex Outcome Treatment
    1 90 DEGREE SCREWDRIVER T-HANDLE| HANDLE FOR 90° SCREWDRIVER