BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG DRIVER

    MDR report key: 11619341 · Received April 6, 2021

    Report

    Report Number
    3012447612-2021-00112
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    UDI-DI
    00880304893566
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND INITIALLY CORRECTED INFORMATION. SUMMARY: THE COMPLAINT IS CONFIRMED FOR ONE (1) OF ONE (1) RETURNED POLARIS 5.5 DRIVER (PN 2000-9061) FOR THE FAILURE OF TIP FRACTURE. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THE TIP HAS FRACTURED OFF. DHR REVIEW AND RELATED ACTIONS PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. 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 A DRIVER TIP BROKE OFF DURING FINAL TIGHTENING. THE BROKEN TIP WAS RETRIEVED AND DISCARDED. ANOTHER DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED IMPACT ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DRIVER TIP BROKE OFF DURING FINAL TIGHTENING. THE BROKEN TIP WAS RETRIEVED AND DISCARDED. ANOTHER DRIVER WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED IMPACT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520010 PLUG DRIVER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. N/A ZB170803 00880304893566

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR