BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINAL SCREWDRIVER SHAFT II

    MDR report key: 12760920 · Received November 7, 2021

    Report

    Report Number
    3003853072-2021-00116
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 15, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    PMA / PMN Number
    K111301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: UDI NUMBER AND H3. ADDITIONAL INFORMATION IN H4 AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALED FRACTURED TIPS ON BOTH INSTINCT JAVA FINAL SCREWDRIVER SHAFTS. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. IT COULD ALSO BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING USE. DHR REVIEW PER DHR REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN THEY LEFT ZIMMER BIOMET CONTROL. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 0

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REFERENCE REPORT 3003853072-2021-00117.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TIPS OF TWO FINAL SCREWDRIVER SHAFTS BROKE INTRA-OPERATIVELY WHILE FINAL TIGHTENING THE BLOCKERS. THE FRAGMENTS WERE RECOVERED AND THE PROCEDURE WAS COMPLETED USING ANOTHER FINAL DRIVER SHAFT WITHOUT PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662669 FINAL SCREWDRIVER SHAFT II INSTINCT JAVA SYSTEM NKB ZIMMER SPINE NA A2649801A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male