BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER

    MDR report key: 10182590 · Received June 22, 2020

    Report

    Report Number
    2939274-2020-02925
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    June 8, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10887587037189
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. H10 ADDITIONAL NARRATIVE: H3, H4, H6: PART: 313.960 LOT: 3191589 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: (B)(6) 2009. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE CRUCIFORM SCREWDRIVER (PRODUCT CODE: 313.960 & LOT NO: 3191589) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, NO BREAKAGE WAS OBSERVED ON THE DEVICE EXCEPT FEW SCRATCHES ON THE HANDLE THAT ARE CONSISTENT WITH THE NORMAL USE. DEVICE FAILURE/DEFECT IDENTIFIED? NO. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS NOT PERFORMED AS NO BREAKAGE WAS OBSERVED ON THE DEVICE. DOCUMENT/SPECIFICATION REVIEW: DRAWING(S) REVIEWED: (CURRENT & MANUFACTURED REVISIONS) INVESTIGATION CONCLUSION. THE COMPLAINT WAS NOT CONFIRMED AS NO BREAKAGE WAS OBSERVED ON THE RECEIVED DEVICE. THERE WERE FEW SCRATCHES ON THE DEVICE HANDLE WHICH ARE CONSISTENT WITH REPEATED USE OF THE DEVICE OVER 11 YEARS. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. 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

    (B)(6). 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 INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE 2.4MM CRUCIFORM SCREWDRIVER WITH HOLDING SLEEVE WAS DAMAGED WITH A BROKEN HANDLE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641796 CRUCIFORM SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 313.96 3191589 10887587037189

    Patients

    Seq Age Sex Outcome Treatment
    1