BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINICA TEMPORARY FIXATION PIN INSERTER

    MDR report key: 11870411 · Received May 24, 2021

    Report

    Report Number
    3012447612-2021-00186
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 26, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    GFC
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D9 AND H3. ADDITIONAL INFORMATION IN D4: UDI NUMBER, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALS THAT THE DEVICE'S RETAINING CLIP IS FRACTURED OFF. 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. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT 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 AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF DURING SURGERY. THE TIP COULD NOT BE FOUND AND MAY HAVE BEEN RETAINED BY THE PATIENT. A K-WIRE WAS USED TO COMPLETE THE CASE.

    Additional Manufacturer Narrative · 1

    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 THE TIP OF THE INSERTER BROKE OFF DURING SURGERY. THE TOP COULD NOT BE FOUND AND MAY HAVE BEEN RETAINED BY THE PATIENT. A K-WIRE WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770117 TRINICA TEMPORARY FIXATION PIN INSERTER DRIVER, SURGICAL, PIN GFC ZIMMER BIOMET SPINE INC. N/A 63452717

    Patients

    Seq Age Sex Outcome Treatment
    1 Other