BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8105MM

    MDR report key: 6412924 · Received March 17, 2017

    Report

    Report Number
    1719045-2017-10231
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 24, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    UDI-DI
    10886982188922
    PMA / PMN Number
    K152239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE USED KWQ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 314.467, LOT# 9981816. SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: MARCH 15, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT STARDRIVE SCREWDRIVER SHAFT T8105MM, PART NUMBER 314.467, LOT NUMBER 9981816). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: THIS COMPLAINT IS CONFIRMED FOR THE THREADED DRILL GUIDE BUT NOT CONFIRMED FOR THE 2 SCREWDRIVER BLADES. THE THREADED DRILL GUIDE HAS MALFORMED DISTAL THREADFORM (POST MANUFACTURING DAMAGE). THE DISTAL MOST THREADFORM HAS A DENT THAT COULD PREVENT IT FROM FUNCTIONING AS INTENDED. THE 2 RETURNED SCREWDRIVER BLADES SHOW MINOR WEAR BUT NO DAMAGE THAT WOULD PREVENT FUNCTION. THE COMPLAINT CONDITIONS FOR THE RETURNED DEVICES WERE NOT ABLE TO BE REPLICATED AT CUSTOMER QUALITY (CQ) BECAUSE THE CONCOMITANT SCREWS AND PLATE INVOLVED IN THE EVENT WERE NOT RETURNED TO CQ. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. PART 1 OF3 PART# 323.061 2.0MM THREADED DRILL GUIDE WITH DEPTH GAUGE: VISUAL INSPECTION: THE DISTAL MALE THREADFORM HAS A NICK/DENT ON THE DISTAL MOST THREAD THAT COULD PREVENT THIS 8+ YEAR OLD REUSABLE INSTRUMENT FROM FUNCTIONING AS INTENDED. DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. PART 2 OF3 PART# 314.467 STARDRIVE SCREWDRIVER SHAFT T8105MM: VISUAL INSPECTION: THE DISTAL TIP SHOWS MINOR WEAR CONSISTENT WITH USAGE. NO DAMAGE THAT WOULD PREVENT FUNCTION WAS OBSERVED UNDER 5X MAGNIFICATION. DRAWING REVIEW: DRAWING WAS REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. PART 3 OF3 PART# 314.453 STARDRIVE SCREWDRIVER SHAFT T855MM: VISUAL INSPECTION: THE DISTAL TIP SHOWS MINOR WEAR CONSISTENT WITH USAGE. NO DAMAGE THAT WOULD PREVENT FUNCTION WAS OBSERVED UNDER 5X MAGNIFICATION. DRAWING REVIEW: DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. MOST LIKELY DUE TO CUMULATIVE WEAR FOR THIS 8+ YEAR OLD REUSABLE INSTRUMENT. 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 THREE DEVICES MALFUNCTIONED DURING A DISTAL RADIUS PROCEDURE ON (B)(6) 2017. THE THREADED DRILL GUIDE WOULD NOT THREAD INTO THE PLATE PROPERLY AND WAS WOBBLY. TWO SCREWDRIVER SHAFTS WOULD NOT SELF-RETAIN SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH OTHER INSTRUMENTS WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED AS FINE WITH NO ISSUES. CONCOMITANT DEVICES REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); SCREWS (PART# 210.1XX, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T8 105MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195699 STARDRIVE SCREWDRIVER SHAFT T8105MM SCREWDRIVERS HXX SYNTHES MONUMENT 9981816 10886982188922

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE (1) UNKNOWN PLATE| TWO (2) UNKNOWN SCREWS