BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X25 SET SCREW INSERTER,

    MDR report key: 8770990 · Received July 9, 2019

    Report

    Report Number
    1526439-2019-51817
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 19, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034214580
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). UDI: (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. VISUAL EXAMINATION AT THE MACROSCOPIC LEVEL REVEALED THAT THE FRACTURE WAS LOCATED AT THE DISTAL TIP OF THE DEVICE. THE FRACTURE ANALYSIS REPORT NOTES THAT THE UNIFORM SURFACE OF THE FRACTURED SURFACE INDICATES THAT THE DEVICE UNDERWENT A STATIC FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THE DISTAL TIP OF THE DEVICE FRACTURING CANNOT BE POSITIVELY DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT NOTES THAT THE UNIFORM OF THE FRACTURE SURFACE INDICATES THAT THE DEVICE UNDERWENT A STATIC FAILURE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), UNKNOWN. THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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 (B)(6) 2019, WHEN THE SURGEON PERFORMED FINAL TIGHTENING DURING POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY DUE TO COMPRESSION FRACTURE AT UNKNOWN LOCATION, HE FOUND OUT THAT THE INSERTOR TIP OF THE SET SCREW WAS BROKEN. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. THERE WAS NO PATIENT HARM OR CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566223 VIPER2 X25 SET SCREW INSERTER, DRIVER, PROSTHESIS HWR DEPUY SPINE INC 286735400 X0710 10705034214580

    Patients

    Seq Age Sex Outcome Treatment
    1