BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY SCW DRIVER SHFT, CANNULTD

    MDR report key: 11619236 · Received April 6, 2021

    Report

    Report Number
    1526439-2021-00625
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 9, 2021
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWR
    UDI-DI
    10705034214177
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. H10 ADDITIONAL NARRATIVE: H6: INVESTIGATION SUMMARY: INVESTIGATION FLOW: DAMAGE: VISUAL INSPECTION: THE POLY SCW DRIVER SHAFT, CANNULTD (PART # 286720000 / LOT # UI290568) WAS RECEIVED AT US CQ. THE DISTAL TIP OF THE DEVICE WAS BROKEN; NO FRAGMENTS WERE RETURNED. THE RECEIVED CONDITION WAS CONSISTENT WITH THE COMPLAINT CONDITION THUS THE COMPLAINT WAS CONFIRMED. THE DEVICE FAILURE/DEFECT WAS IDENTIFIED. THE DISTAL TIP WAS BROKEN. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE RECEIVED DEVICE WAS NOT PERFORMED AT CQ DUE TO POST MANUFACTURING DAMAGE. DRAWING(S) REVIEWED: CURRENT & MANUFACTURED REVISIONS. CONCLUSION: THE OVERALL COMPLAINT WAS CONFIRMED FOR THE RECEIVED POLY SCW DRIVER SHAFT, CANNULTD (PART # 286720000 / LOT # UI290568) 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 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. 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

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE TIP OF THE POLY SCREWDRIVER WAS STRIPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DRIVER. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL IMPACT. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515685 POLY SCW DRIVER SHFT, CANNULTD DRIVER HWR DEPUY SPINE INC 286720000 UI290568 10705034214177

    Patients

    Seq Age Sex Outcome Treatment
    1