BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN

    MDR report key: 10181291 · Received June 22, 2020

    Report

    Report Number
    1526439-2020-01226
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    March 25, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. THE POLY SCW DRIVER SHFT, CANNULTD (PART # 286720000 / LOT # U1218301) WAS RECEIVED AT (B)(4). THE DISTAL TIP OF THE DEVICE WAS BROKEN, NO FRAGMENTS WERE RETURNED. THERE WERE SURFACE SCRATCHES AND NICKS CONSISTENT WITH NORMAL WEAR ALONG THE SHAFT OF THE DEVICE. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED POLY SCW DRIVER SHFT, CANNULTD (PART # 286720000 / LOT # U1218301) AS THE DISTAL TIP OF THE DEVICE WAS BROKEN. ALTHOUGH NO DEFINITIVE ROOT-CAUSE CAN BE DETERMINED IT IS POSSIBLE THE DEVICE EXPERIENCED UNINTENDED FORCES LEADING TO THE BREAKAGE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: A REVIEW OF THE RECEIVING INSPECTION (RI) FOR POLY SCW DRIVER SHFT, CANNULTD, WAS CONDUCTED IDENTIFYING THAT LOT NUMBER U1218301 WAS RELEASED IN A SINGLE BATCH. BATCH 1: LOT UNITS WERE RELEASED ON 04-FEB-2015 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. 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 UNKNOWN DATE DURING AN INSPECTION OF SETS, THE DEVICES WERE ALL FOUND TO BE NON-FUNCTIONAL AND BROKEN. THE SET SCREW INSERTER WAS OVER TIGHTENED WHILE TIGHTENING THE SET SCREWS AND THE DRIVER TIP SNAPPED INTO THE HEAD OF THE SET SCREW. THE BROKEN PIECE WAS EASILY REMOVED. THE DEVICES INVOLVED WERE VIPER POLYAXIAL DRIVERS, T20 DRIVER, FINAL TIGHTENER, SET SCREW INSERTER, AND ALSO SOME SKYLINE SCREW DRIVERS. THERE IS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644710 VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN DRIVER, PROSTHESIS HWR DEPUY SPINE INC 286720000 U10412 10705034214177

    Patients

    Seq Age Sex Outcome Treatment
    1 SKYLINE EXPANSION TIP DRIVER| VIPER UNIVERSAL POLY DRIVER| VIPER2 FINAL TIGHTENER DRIVER| VIPER2 T20 HEXLOBE DRIVER SHAF| VIPER2 X25 SET SCREW INSERTER,