BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

    MDR report key: 13450549 · Received February 4, 2022

    Report

    Report Number
    2939274-2022-00354
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 6, 2022
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTC
    UDI-DI
    10705034773292
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. DATE OF CONCOMITANT THERAPY IS JANUARY 6, 2021. PART: 388.50 LOT: T173508 MANUFACTURING SITE: TUTTLINGEN RELEASE TO WAREHOUSE DATE: MAY 10, 2019 A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 ROD INTRODUCTN PLIERS F/ SIDE-OPEN IMPS WAS BENT AND DEFORMED. A FUNCTIONAL ASSESSMENT WAS PERFORMED AT SERVICE AND REPAIR. THE RATCHETING MECHANISM DID NOT WORK. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. THE OBSERVED CONDITION OF THE DEVICE WAS CONSISTENT WITH A RANDOM COMPONENT FAILURE THAT MAY HAVE BEEN CAUSED BY EXPOSURE TO UNINTENDED FORCES. 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 ROD INTRODUCTN PLIERS F/ SIDE-OPEN IMPS WOULD CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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. SERVICE AND REPAIR EVALUATION: THE CUSTOMER REPORTED THE DEVICE HAD ISSUES. THE REPAIR TECHNICIAN REPORTED THE ITEMS RATCHETING MECHANISM IS FAULTY AND DOES NOT WORK. THE DEVICE IS BENT AND DEFORMED. BENT IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE PER THE INSPECTION SHEET. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO CUSTOMER QUALITY. THE EVALUATION WAS CONFIRMED. 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

    OCCUPATION: INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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

    IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE. TWO USS PERSUADERS WERE UNABLE TO BE USED FOR THE PROCEDURE DUE TO MECHANICAL ISSUES. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402532 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS, SURGICAL HTC WRIGHTS LANE SYNTHES USA PRODUCTS LLC 388.50 T173508 10705034773292

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ROD INTRODUCTN PLIERS F/ SIDE-OPEN IMPS.