BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY SCW DRIVER SHFT, CANNULTD

    MDR report key: 16495066 · Received March 7, 2023

    Report

    Report Number
    1526439-2023-00418
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    January 1, 2023
    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
    PHYSICIAN
    Health Professional
    Yes

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. A REVIEW OF THE RECEIVING INSPECTION (RI) POLY SCW DRIVER SHFT, CANNULTD WAS CONDUCTED IDENTIFYING THAT LOT NUMBER UI375472 WAS RELEASED IN ONE BATCH. SUPPLIER: ORCHID BRIDGEPORT BATCH1: LOT UNITS WERE RELEASED ON 23 AUG 2021 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 PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE THREAD TIP OF THE POLY SCW DRIVER SHFT, CANNULTD WAS STRIPPED. THE OBSERVED CONDITION WAS CONSISTENT AS AN END OF LIFE INDICATOR FOR THE DEVICE. NO OTHER ISSUES WERE IDENTIFIED. AFTER A VISUAL INSPECTION PER GUIDANCE PROVIDED IN WINDCHILL DOCUMENT , IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT DEVICE WAS WORN FROM REPEATED USE AND SERVICING; THEREFORE, FURTHER INVESTIGATION FOR THE REPORTED COMPLAINT DEVICE IS NOT REQUIRED. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE POLY SCW DRIVER SHFT, CANNULTD WOULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. IT WAS DETERMINED THAT THE REUSABLE INSTRUMENT WAS WORN FROM REPEATED USE AND SERVICING. 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. DRAWING/SPECIFICATIONS REVIEWED: THE FOLLOWING DOCUMENT WAS REVIEWED: WINDCHILL DOCUMENT. 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 · 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 AVAILABLE FOR EVALUATION: 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CLEANING PROCESS THE CSSD MANAGER NOTICED THAT THE SCREWDRIVER TIP WAS DEFECTIVE AND THAT THE TROCAR DOES NOT HOLD THE SLEEVE TIGHTLY. NO PATIENT IMPACT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) POLY SCW DRIVER SHFT, CANNULTD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625660 POLY SCW DRIVER SHFT, CANNULTD DRIVER HWR DEPUY SPINE INC 286720000 UI375472 10705034214177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VIPER2 PEDICLE PREP CANNULA