BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM HEX FLEXIBLE SCREWDRIVER

    MDR report key: 9676976 · Received February 6, 2020

    Report

    Report Number
    2939274-2020-00661
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 1, 2020
    Report Date
    January 15, 2020
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    LXH
    UDI-DI
    10886982070449
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. H3, H4, H6 INVESTIGATION SUMMARY. VISUAL INSPECTION: THE 5MM HEX FLEXIBLE SCREWDRIVER (P/N 03.037.028, L/N 9841618) WAS RECEIVED BROKEN AT THE MOST DISTAL LASER CUT TEETH SEGMENT ON THE SHAFT. THE SHAFT WAS COMPLETELY BROKEN INTO 2 PIECES AND RECEIVED AT US CQ. THIS DAMAGE IS CONSISTENT WITH A DEVICE THAT WAS LIKELY SUBJECTED TO THE UNANTICIPATED TORSIONAL FORCES DURING THE TIGHTENING PROCESS, RESULTING IN THE SHAFT OF THE SCREWDRIVER TWISTING AND BREAKING OFF. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS PERFORMED AT CQ THE SHAFT DIAMETER OF THE DEVICE WAS INTENDED TO BE MEASURING FROM 7.985 MM TO 8 MM AND WAS MEASURED TO BE 7.99 MM WHICH WAS WITHIN THE SPECIFICATION AS PER THE DRAWING. DOCUMENT/SPECIFICATION REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED. -FLEXIBLE SCREWDRIVER HEX 5. -FLEXIBLE SHAFT. COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED WAS BROKEN. HENCE CONFIRMING THE ALLEGATION. CONCLUSION: THE COMPLAINT WAS CONFIRMED FOR THE 5MM HEX FLEXIBLE SCREWDRIVER (P/N 03.037.028, L/N 9841618) AS THE SHAFT OF THE DEVICE WAS COMPLETELY BROKEN. THE UNINTENDED EXTERNAL FORCES MIGHT HAVE CONTRIBUTED TO THE REPORTED COMPLAINT CONDITION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE BREAKAGE 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 HISTORY: PART: 03.037.028, LOT: 9841618, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: 03.JUN.2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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

    EVENT DATE: UNKNOWN DATE IN 2019. INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. 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 (B)(6) 2020, THE 5MM HEXAGONAL FLEXIBLE SCREWDRIVER FROM TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) SET BROKE DURING THE ADVANCEMENT OF THE LOCKING MECHANISM. THE NEEDLE DRIVER WAS USED TO REMOVING THE BROKEN SEGMENT FROM THE SURGICAL SITE. INTRAOPERATIVE IMAGING SHOWED NO REMAINING FRAGMENTS IN THE SURGICAL SITE. THERE WAS A FIVE MINUTE SURGICAL DELAY REPORTED. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#UNKNOWN, LOT#UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5MM HEX FLEXIBLE SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138458 5MM HEX FLEXIBLE SCREWDRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.037.028 9841618 10886982070449

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR UNK - SCREWS: LOCKING