BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN SITU ROD BENDER, LEFT (DIA. 3.8MM)

    MDR report key: 7084751 · Received December 5, 2017

    Report

    Report Number
    3012447612-2017-00670
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    June 7, 2017
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXW
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED ROD BENDER WAS EVALUATED. THE TIP WAS FOUND TO HAVE FRACTURE OFF. THE CAUSE IS LIKELY ATTRIBUTED TO FATIGUE FROM REPETITIVE USE, WHICH ALLOWED IT BREAK WHILE BENDING A COBALT CHROME ROD. 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 A PIECE OF A ROD BENDER BROKE WHILE THE SURGEON WAS USING IT TO BEND A COCR ROD IN-SITU DURING SURGERY. THE BROKEN PIECE WAS RETRIEVED FROM THE WOUND. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864953 IN SITU ROD BENDER, LEFT (DIA. 3.8MM) BENDER HXW ZIMMER BIOMET SPINE INC. NA 62485606

    Patients

    Seq Age Sex Outcome Treatment
    1