BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY SCW DRIVER SHFT, CANNULTD

    MDR report key: 12666133 · Received October 20, 2021

    Report

    Report Number
    1526439-2021-02226
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 23, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034214177
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON AN UNKNOWN DATE IN 2021. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN ANTERIOR/POSTERIOR LUMBAR FUSION PROCEDURE ONE (1) VIPER UNIVERSAL POLY DRIVER WAS BROKEN, AND TWO (2) T20 DRIVER SHAFTS WERE STRIPPED. THE SURGEON WAS PLACING UNKNOWN SCREWS IN THE PATIENT WHEN TWO (2) POLY SCREWDRIVER SHAFTS TIPS BROKE OFF. HE THEN ATTEMPTED TO USE THE VIPER2 T20 HEXLOBE DRIVER AND T20 SCREWDRIVER SHAFT WHICH BOTH STRIPPED. HE ADVANCED USING THE VIPER UNIVERSAL POLY DRIVER AND THE TIP OF THE DRIVER WAS FOUND TO BE BROKEN ON THE BACK TABLE AFTER IT WAS TAKEN OUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 5 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565045 POLY SCW DRIVER SHFT, CANNULTD DRIVER, PROSTHESIS HWR DEPUY SPINE INC 286720000 10705034214177

    Patients

    Seq Age Sex Outcome Treatment
    1 POLY SCW DRIVER SHFT, CANNULTD| T20 SCREWDRIVER SHAFT| UNKNOWN AWLS| UNKNOWN SCREWS| VIPER UNIVERSAL POLY DRIVER| VIPER2 T20 HEXLOBE DRIVER SHAF