BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SCREW INSERTER

    MDR report key: 8704340 · Received June 17, 2019

    Report

    Report Number
    3012447612-2019-00267
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 24, 2019
    Report Date
    October 16, 2019
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UDI NUMBER; THE RETURNED CYPHER MIS SCREW INSERTERS WERE EVALUATED. THE ADDITION OF BONE CEMENT TO THE PEDICLE SCREW HOLES PRIOR TO SCREW INSERTION IS NOT PART OF THE INSTRUCTIONS IN THE STG, AND IS THE MOST LIKELY CAUSE OF THE FRACTURE AS IT LIKELY INCREASED THE FORCES DURING INSERTION/TORQUING, OVERCOMING THE MATERIAL PROPERTIES OF THE SCREW INSERTERS. THERE WERE NO OTHER SIGNS OF DAMAGE ON THE DEVICE. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN INSTRUCTIONS REGARDING PROPER DEVICE USAGE.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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. REFERENCE REPORT 3012447612-2019-00268.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF TWO DRIVERS BROKE OFF DURING PEDICLE SCREW INSTALLATION WITHIN SURGERY; IT IS BELIEVED THAT THE TIPS REMAIN STUCK IN THE IMPLANTED SCREW HEADS. THE SURGEON INSTALLED THE SCREWS, THEN REMOVED THEM AND FILLED THE SCREW HOLES WITH BONE CEMENT PRIOR TO REINSTALLING THE SCREWS. IT WAS DURING THE INSTALLATION WITH THE CEMENT IN THE SCREW HOLES THAT THE TIPS OF THE DRIVERS BROKE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF TWO DRIVERS BROKE OFF DURING PEDICLE SCREW INSTALLATION WITHIN SURGERY; IT IS BELIEVED THAT THE TIPS REMAIN STUCK IN THE IMPLANTED SCREW HEADS. THE SURGEON INSTALLED THE SCREWS, THEN REMOVED THEM AND FILLED THE SCREW HOLES WITH BONE CEMENT PRIOR TO REINSTALLING THE SCREWS. IT WAS DURING THE INSTALLATION WITH THE CEMENT IN THE SCREW HOLES THAT THE TIPS OF THE DRIVERS BROKE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIPS OF TWO DRIVERS BROKE OFF DURING PEDICLE SCREW INSTALLATION WITHIN SURGERY; IT IS BELIEVED THAT THE TIPS REMAIN STUCK IN THE IMPLANTED SCREW HEADS. THE SURGEON INSTALLED THE SCREWS, THEN REMOVED THEM AND FILLED THE SCREW HOLES WITH BONE CEMENT PRIOR TO REINSTALLING THE SCREWS. IT WAS DURING THE INSTALLATION WITH THE CEMENT IN THE SCREW HOLES THAT THE TIPS OF THE DRIVERS BROKE. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497866 CYPHER SCREW INSERTER SCREWDRIVER HXX ZIMMER BIOMET SPINE INC. NA 673820

    Patients

    Seq Age Sex Outcome Treatment
    1 Other