BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SDDRIVE SCREWDRIVER T8

    MDR report key: 12501528 · Received September 20, 2021

    Report

    Report Number
    2939274-2021-05600
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Report Date
    August 23, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982071859
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. H3, H4, H6: PART # 03.110.007, SYNTHES LOT # H891253, SUPPLIER LOT # H891253, RELEASE TO WAREHOUSE DATE: SEPTEMBER 25, 2020, SUPPLIER: (B)(4), NO 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 SDDRIVE SCREWDRIVER T8 (P/N: 03.110.007, LOT #:H891253) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DEVICE WAS SLIGHTLY STRIPPED. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. FUNCTIONAL TEST: THE FUNCTIONAL TEST CANNOT BE PERFORMED DUE TO ABSENCE OF MATING DEVICE. THE ABILITY OF SCREWDRIVER TO HOLD/RETAIN THE SCREW/MATING DEVICE CANNOT BE CONFIRMED. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? UNABLE TO PERFORM. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. SPECIFIED DIMENSIONS: SHAFT OD. MEASURED DIMENSIONS: SHAFT OD: CONFORMING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. T8 ONE PIECE SCREWDRIVER: CURRENT & MANUFACTURED REVISIONS. SCREWDRIVER SHAFT T8 ONE PIECE SCREWDRIVER: CURRENT & MANUFACTURED REVISIONS. COMPLAINT CONFIRMED? YES. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE SDDRIVE SCREWDRIVER T8 (P/N: 03.110.007, LOT #: H891253). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; 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, STERILE PROCESSING(SPD) REPORTED THAT THE SCREWDRIVER HAS A TWISTED TIP AND THE SCREWS DO NOT SELF-RETAIN ON THE SCREWS ANYMORE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE(1) DEVICE. THIS REPORT IS FOR (1)SDDRIVE SCREWDRIVER T8. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397755 SDDRIVE SCREWDRIVER T8 SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.110.007 H891253 10886982071859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: LOCKING