BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORQUE INDICATING WRENCH, 110IN-LBS

    MDR report key: 6949992 · Received October 13, 2017

    Report

    Report Number
    3012447612-2017-00559
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 20, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXC
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TORQUE INDICATING WRENCH WAS EVALUATED. THE TIP WAS CONFIRMED TO HAVE BROKEN OFF AND THE 0 INDICATING LINES WERE NOT ALIGNED. THE TOQUE OUTPUT WAS FOUND TO BE BELOW THE SPECIFIED LIMIT. THE LINE MISALIGNMENT WAS LIKELY CAUSED BY DEFORMATION OF THE INTERNAL COMPONENTS AS A RESULT OF A LARGE TORQUE BEING APPLIED TO THE DEVICE. IT IS LIKELY THAT THE LARGE TORQUE APPLICATION WOULD HAVE ALSO CAUSED THE TIP TO FRACTURE. THE DEVICE LABELING PROVIDES SUFFICIENT INSTRUCTIONS REGARDING THE USE OF THIS INSTRUMENT, STATING THE DEVICE GIVES A VISUAL INDICATION OF APPROPRIATE TORQUE AND NOT A TACTILE SENSATION OR AUDIBLE CLICK OF WHEN THE PROPER TORQUE IS REACHED, AND WARNS OF POSSIBLE DEVICE DAMAGE IF OVER-TORQUED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH MAY 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 THE TIP OF A DRIVER FRACTURED OFF DURING SURGERY. THE PIECE WAS RETRIEVED FROM WITHIN THE WOUND. AN ALTERNATIVE INSTRUMENT WAS NOT NEEDED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT IMPACTS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727586 TORQUE INDICATING WRENCH, 110IN-LBS WRENCH (RATCHETING HANDLES) HXC ZIMMER BIOMET SPINE INC. NA B342286-14

    Patients

    Seq Age Sex Outcome Treatment
    1