BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE TI 25MM U-JOINT AWL

    MDR report key: 6099811 · Received November 14, 2016

    Report

    Report Number
    3004485144-2016-00310
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 18, 2016
    Report Date
    June 2, 2017
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    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 DURING SURGERY, THE DEPTH STOP RING OF A U-JOINT AWL BROKE OFF AND FELL INTO THE WOUND. IT WAS PROMPTLY REMOVED SO THE PATIENT DID NOT RETAIN A FOREIGN BODY. A DIFFERENT INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE TO REMOVE THE BROKEN PIECE, BUT THERE WERE NO REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749868 SOLITAIRE TI 25MM U-JOINT AWL AWL HWJ ZIMMER BIOMET SPINE N/A PR27E

    Patients

    Seq Age Sex Outcome Treatment
    1