BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG DRIVER

    MDR report key: 10521190 · Received September 11, 2020

    Report

    Report Number
    3012447612-2020-00542
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 26, 2020
    Report Date
    February 4, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. THE COMPLAINT IS CONFIRMED FOR THE REPORTED FAILURE OF TWISTED/DEFORMED TIP. THE VISUAL INSPECTION CONFIRMED THAT THE TIPS OF THE PLUG DRIVERS WERE BOTH TWISTED. PER THE DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS ARE REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING FINAL TIGHTENING, ADDITIONAL FORCE HAD TO BE APPLIED TO THE TORQUE WRENCH HANDLE. TWO SEPARATE PLUG DRIVERS BECAME DEFORMED (NO TIPS BROKE OFF, THE SCREWS COULD BE TIGHTENED AND IMPLANTS WERE NOT DAMAGED). THERE WAS NO DELAY OR IMPACT ON THE PATIENT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 94522, ARRAY 5.5 QC TORQ WRENCH HNDL DLE, LOT # 830417. CATALOG #: 2000-9061, POL 5.5 TI PLUG DRIVER, LOT # ZB150803. (B)(6). WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3012447612-2020-00539, 3012447612-2020-00541.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL TIGHTENING, ADDITIONAL FORCE HAD TO BE APPLIED TO THE TORQUE WRENCH HANDLE. TWO SEPARATE PLUG DRIVERS BECAME DEFORMED (NO TIPS BROKE OFF, THE SCREWS COULD BE TIGHTENED AND IMPLANTS WERE NOT DAMAGED). THERE WAS NO DELAY OR IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985615 PLUG DRIVER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. N/A ZB170804

    Patients

    Seq Age Sex Outcome Treatment
    1