BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER 5.5 TITANIUM CORTICAL FIXATION SCREW, 6X40MM

    MDR report key: 3870164 · Received June 12, 2014

    Report

    Report Number
    1526439-2014-11611
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. 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

    THE MANUFACTURING SITE/ESTABLISHMENT NAME SECTION INCORRECTLY IDENTIFIED (B)(4) AS THE STATE. THE MANUFACTURING SITE IS MEDOS INTERNATIONAL SARL, (B)(4). 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

    (B)(4). 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

    ONE (1) VIPER 5.5 TI CORTICAL FIX CANNULATED SCREW 6X40MM [PRODUCT CODE: 1867-31-640, LOT NO: APMCLG] WAS RETURNED TO THE COMPLAINTS HANDLING UNIT (CHU) FOR EVALUATION. VISUAL VERIFICATION INDICATED THAT THE POLYAXIAL SCREW CAP (1797-13-003) HAD BEEN SEPARATED FROM ITS INTENDED POSITION. NO OTHER DEFECTS WERE OBSERVED DURING EVALUATION. ADDITIONALLY, IT SHOULD BE NOTED THAT INDICATIONS OF SWAGING WERE PRESENT ON THE TULIP HEAD CONFIRMING THAT THE CAP OF THE POLYAXIAL SCREW WAS ASSEMBLED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE VIPER 5.5 TI CORTICAL FIX CANNULATED SCREW 6X40MM WAS CONDUCTED. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12-MONTH REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE VIPER 5.5 TI CORTICAL FIX CANNULATED SCREW 6X40MM WAS CONDUCTED ON THE PRODUCT FAMILY FROM THIS COMPLAINT FILE BECAUSE OF A SIMILAR TOP LOADING GEOMETRIC DESIGN AND FUNCTIONALITY OF THE TULIP HEAD. NO SYSTEMIC TREND WAS IDENTIFIED AS A PART OF THE EVALUATION. THE ROOT CAUSE OF THE POLYAXIAL SCREW CAP BECOMING SEPARATED FROM ITS INTENDED POSITION CANNOT POSITIVELY BE DETERMINED. HOWEVER, IT IS LIKELY THAT THE SCREW TULIP HEAD WAS SUBJECTED TO A HIGHER THAN ANTICIPATED LOAD RESULTING IN THE CAP TO SEPARATE FROM ITS INTENDED LOCATION. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE NOR HAS THERE BEEN ANY SYSTEMATIC TREND THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    INTERNATIONAL AFFILIATE REPORTS THE INSIDE OF THE SCREW HEAD WAS BROKEN DURING THE SURGERY. AFTER SCREW INSERTION, WHEN TRYING TO TIGHTEN IT DEEPLY WITH A DRIVER FOR FINE ADJUSTMENT, THE SURGEON NOTED THE ABNORMALITY INSIDE THE SCREW HEAD. THE SCREW WAS REMOVED INTRA-OPERATIVELY AND IT SEEMED THAT THE WASHER PART WITHIN THE SCREW HEAD WHICH SHOULD FIT TO A ROD, IE. THE INNER SADDLE, WAS BROKEN AND NOT FULLY SEATED. NO BROKEN PIECE WAS LEFT IN THE PATIENT. ANOTHER SCREW WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS EXTENDED BY 5 MIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347573 VIPER 5.5 TITANIUM CORTICAL FIXATION SCREW, 6X40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APMCLG

    Patients

    Seq Age Sex Outcome Treatment
    1