BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90 SCREWDRIVER

    MDR report key: 13424031 · Received February 2, 2022

    Report

    Report Number
    2939274-2022-00327
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    DZI
    UDI-DI
    10887587013329
    PMA / PMN Number
    K082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ONLY EVENT YEAR IS KNOWN. (B)(4). REPORTER IS A SYNTHES EMPLOYEE. 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.

    Additional Manufacturer Narrative · 0

    ONLY EVENT YEAR IS KNOWN. (B)(4). REPORTER IS A SYNTHES EMPLOYEE. 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.

    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. LOT AND EXPIRATION DATE PART: 03.505.003 LOT: 8190939 MANUFACTURING SITE: SELZACH SUPPLIER: DIENER AG PRECISION MACHINING RELEASE TO WAREHOUSE DATE: JULY 11, 2019 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE SHAFT FOR 90 SCREWDRIVER WAS RETURNED AND RECEIVED FOR ANALYSIS. UPON VISUAL INSPECTION, THE BALL BEARING IS MISSING FROM THE PROXIMAL END OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES DIMENSIONAL INSPECTION: THE DIAMETER OF THE PROXIMAL END WAS MEASURED TO BE WITHIN THE SPECIFICATION. THE DIAMETER OF THE SHAFT WAS MEASURED TO BE WITHIN THE SPECIFICATION. THE LENGTH OF THE DEVICE WAS MEASURED TO BE WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW: SHAFT COMPLETE CURRENT AND MANUFACTURED REVISION SHAFT F/SCREWDRIVER 90° CURRENT AND MANUFACTURED REVISION GENERAL TOLERANCING AND DIMENSIONING DOCUMENT COMPLAINT CONFIRMED: YES, THE COMPLAINT CAN BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. INVESTIGATION CONCLUSION: THE REPORTED CONDITION OF THE COMPLAINT DEVICE (SHAFT FOR 90 SCREWDRIVER) IS CONFIRMED, THE BALL BEARING IS MISSING. 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. D1 ADDITIONAL DEVICE PRODUCT CODES: DZJ AND HXX. D4: CATALOG AND UDI

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION ITEMS ARE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION ITEMS ARE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) DRIVESHAFT FOR SCREWDRIVER 90°. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296781 SHAFT FOR 90 SCREWDRIVER DRILL, BONE, POWERED DZI WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.505.006 8190939 10887587013329

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown