BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90 SCREWDRIVER

    MDR report key: 10580952 · Received September 24, 2020

    Report

    Report Number
    2939274-2020-04302
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Report Date
    September 1, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587013305
    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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. H10 ADDITIONAL NARRATIVE: D10 H3, H4, H6 INVESTIGATION SUMMARY VISUAL INSPECTION: THE HANDLE FOR 90° SCREWDRIVER (PRODUCT CODE: 03.505.004 & LOT NO: 8192574) WAS RECEIVED AT US CQ. THE VISUAL INSPECTION OF THE RECEIVED DEVICE INDICATED THAT THE THREADS AT THE DISTAL END OF THE DEVICE WERE STRIPPED. THE STRIPPED THREADS CONDITION OF THE COMPLIANT DEVICE IS CONSISTENT AS AN END OF THE LIFE INDICATOR FOR THE DEVICE. DUE TO THE STRIPPED/WORN CONDITION, THE COMPLAINT CAN BE CONFIRMED AS THE DEVICE IS NOW INOPERABLE. THE RECEIVED CONDITION IS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT IS CONFIRMED. CONCLUSION: AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT, IT IS DETERMINED THAT THE REUSABLE INSTRUMENT IS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. 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 HISTORY PART NUMBER: 03.505.004 LOT NUMBER: 8192574 MANUFACTURING SITE: SELZACH SUPPLIER: DIENER AG PRECISION MACHINING RELEASE TO WAREHOUSE DATE: (B)(6) 2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S 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 PRODUCT CODE DZI, DZJ. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS JNJ REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. 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) 2020, THE MESH CUTTER, RIGHT ANGLE BENDER, PLATE CUTTER, 90 DEGREE SCREWDRIVER T-HANDLE, HANDLE FOR 90° SCREWDRIVER, SHAFT FOR 90° SCREWDRIVER, AND MATRIX RIB SCREWDRIVER BLADE SELF-RETAINING F/90° SCREWDRIVER CHECK ON INVENTORY ITEMS IN A TERRITORY WITH UNKNOWN ALLEGATIONS. THE HANDLE FOR 90° SCREWDRIVER WOULD STRIP OUT/NOT TURN SCREW WHEN TESTED. THE SHAFT FOR 90° SCREWDRIVER WOULD STRIP OUT/NOT TURN SCREW WHEN TESTED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWENTY-FIVE (25) DEVICES. THIS REPORT IS FOR (1) HANDLE FOR 90° SCREWDRIVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044846 HANDLE FOR 90 SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.004 8192574 10887587013305

    Patients

    Seq Age Sex Outcome Treatment
    1