BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY SCW DRIVER SHFT, CANNULTD

    MDR report key: 11672898 · Received April 15, 2021

    Report

    Report Number
    1526439-2021-00736
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    March 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. H3, H6: INVESTIGATION SUMMARY. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE POLY SCW DRIVER SHAFT, CANNULTD (P/N: 286720000, LOT #: UI290568) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT A SMALL PORTION OF THE DISTAL TIP OF THE DEVICE WAS BROKEN OFF AND NOT RETURNED. THE DEVICE FAILURE/DEFECT WAS IDENTIFIED. DIMENSIONAL INSPECTION: THE OUTER DIAMETER OF THE SHAFT NEAR BROKEN TIP WAS MEASURED. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. THE COMPLAINT IS CONFIRMED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE POLY SCW DRIVER SHAFT, CANNULTD (P/N: 286720000, LOT #: UI290568). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. 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 SHAFT, CANNULTD WAS CONDUCTED IDENTIFYING THAT LOT NUMBER UI290568 WAS RELEASED IN A SINGLE BATCH. BATCH1: LOT QTY OF (B)(4) UNITS WERE RELEASED ON JAN 23, 2018 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. DEVICE HISTORY REVIEW: 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PART RETURNED. INITIAL REPORTER IS J&J COMPANY REPRESENTATIVE THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE. UPON INSPECTING THE KIT FOUND THESE INSTRUMENTS WITH A BROKEN TIP. THE INSTRUMENTS WERE NOT BEING USED IN SURGERY. THERE IS NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD THIS REPORT IS 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572271 POLY SCW DRIVER SHFT, CANNULTD DRIVER HWR DEPUY SPINE INC 286720000 UI290568 10705034214177

    Patients

    Seq Age Sex Outcome Treatment
    1 POLY SCW DRIVER SHFT, CANNULTD| POLY SCW DRIVER SHFT, CANNULTD| T20 SCREWDRIVER SHAFT| VIPER UNIVERSAL POLY DRIVER| VIPER UNIVERSAL POLY DRIVER