BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNER SHAFT FOR REMOVAL SCREWDRIVER

    MDR report key: 4242368 · Received November 11, 2014

    Report

    Report Number
    2520274-2014-14646
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: TWO INNER SHAFTS FOR REMOVAL SCREWDRIVER (PART 03.647.972 LOTS 7726748 AND 7776319) WERE RETURNED FOR REPORTEDLY BREAKING DURING REMOVAL OF A ZERO-P VA SCREW. THE INNER SHAFT IS A COMPONENT OF THE REMOVAL SCREWDRIVER (PART 03.647.971) AND IS INCLUDED IN THE SET AS AN ALTERNATIVE METHOD FOR REMOVING SCREWS. THE TECHNIQUE GUIDE INCLUDES A CAUTION STATING IF THE INNER SHAFT IS NOT FULLY ENGAGED PRIOR TO ATTEMPTING SUBSEQUENT SCREW REMOVAL TECHNIQUE STEPS, BREAKAGE OF THE DRIVER MAY OCCUR AND COULD POTENTIALLY HARM THE PATIENT. THE PART HAS MINIMAL WEAR AT THE PROXIMAL END CONSISTENT WITH NORMAL USE. PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION. THE TWO DRIVERS WERE RETURNED WITH THE DISTAL THREADS BROKEN OFF. THE TIP IS DESIGNED SO THE THREADED REMOVAL SHAFT IS SMALL ENOUGH TO ACCESS THE INTERNAL THREADS IN THE HEAD OF THE SCREW. DUE TO THE SMALL SIZE OF THE INNER SHAFT, IT IS SUSCEPTIBLE TO BREAKAGE WHEN MISUSED. THE SHAFT IS MADE FROM 316L STAINLESS STEEL AND ALTHOUGH STRONGER STEELS COULD BE USED, IT IS UNKNOWN IF THEY WOULD HAVE PREVENTED THE BREAKAGE OF THE SHAFTS UNDER THE CONDITIONS IN WHICH THEY WERE USED. THE COMPONENTS COULD HAVE BROKEN FROM NOT FULLY ENGAGING THE SCREW PRIOR TO ATTEMPTING REMOVAL AS CAUTIONED IN THE TECHNIQUE GUIDE OR DUE TO THE SECURING MECHANISM ON THE ZERO-P PLATE NOT BEING DEPRESSED TOWARDS THE MIDLINE. THE TECHNIQUE AND CONDITIONS DURING REMOVAL ARE UNKNOWN AND SO THE ROOT CAUSE IS INDETERMINATE. THE INNER SHAFTS WERE RETURNED BROKEN AND THEREFORE THE COMPLAINT IS CONFIRMED. THE COMPLAINT CONDITION MAY HAVE BEEN CAUSED BY THE USER NOT FULLY ENGAGING THE SCREW OR DEPRESSING THE SECURING MECHANISM ON THE PLATE BEFORE ATTEMPTING REMOVAL. THE SMALL SIZE OF THE INNER SHAFT MAKES THE COMPONENT SUSCEPTIBLE TO DAMAGE WHEN MISUSED. THE USE OF THE DEVICE IS UNKNOWN AND THEREFORE THE ROOT CAUSE IS INDETERMINATE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT: NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD AS WELL OF THE SUBASSEMBLY (B)(4) LOT 7773619 AND AS WELL THE FINISHED PART 03.647.972 LOT 7786154 SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DURING (ANTERIOR CERVICAL DISCECTOMY AND FUSION) ACDF PROCEDURE, THE SURGEON REPOSITION THE ZERO-P VARIABLE ANGLE IMPLANT. THE REMOVAL DRIVER TIP BROKE ON THE BACK TABLE WHILE THE SCREW WAS BEING REMOVED FROM THE DEVICE. THE TIP WAS REPLACED WITH THE BACKUP TIP. THE SURGEON ATTEMPTED TO REMOVE ANOTHER SCREW FROM THE ZERO-P DEVICE, WHILE REMOVING THIS SCREW THE SECOND TIP BROKE IN THE SCREW. THERE WERE LOOSE THREADS BUT NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS A THIRTY MINUTE TIME DELAY. THERE WAS NO REPORTED HARM TO THE PATIENT. THE SURGEON WAS ABLE TO REMOVE THE SCREW AND COMPLETE THE CASE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727690 INNER SHAFT FOR REMOVAL SCREWDRIVER INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES HAGENDORF 7776319

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR