BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90 SCREWDRIVER

    MDR report key: 10043566 · Received May 11, 2020

    Report

    Report Number
    2939274-2020-02303
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 27, 2020
    Report Date
    April 27, 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
    AZ, 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: 03.505.004, LOT: 8192574, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: OCTOBER 04, 2019. A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE, NO MANUFACTURING RECORD EVALUATION IS REQUIRED. VISUAL INSPECTION: THE HANDLE FOR 90 DEGREES SCREWDRIVER WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE WERE NO DEFECTS FOUND BESIDES NORMAL SURFACE WEAR. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED DEVICE. DOCUMENT/SPECIFICATION REVIEW THE FOLLOWING DRAWING, REFLECTING THE CURRENT REVISION, WAS REVIEWED: GRIFF 2. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS NOT CONFIRMED FOR THE HANDLE FOR 90 DEGREES SCREWDRIVER. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE 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

    ADDITIONAL CODES DZI, DZJ. THE DEVICE HAS BEEN 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 DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE HANDLE OF THE 90 DEGREE SCREWDRIVER WAS STRIPPED. IT WAS ALSO MENTIONED THAT THE REPORTED SCREWDRIVER DID NOT WORK PROPERLY WHERE IT DOES NOT LOCK SCREW INTO THE PLATE AND JUST KEEPS SPINNING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER SCREWDRIVER HANDLE. THERE WAS NO PATIENT CONSEQUENCE REPORTED THIS COMPLAINT INVOLVES 1 DEVICE FOR HANDLE FOR 90° SCREWDRIVER. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREWDRIVER SHAFT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507202 HANDLE FOR 90 SCREWDRIVER SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.004 8192574 10887587013305

    Patients

    Seq Age Sex Outcome Treatment
    1