BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY

    MDR report key: 17785551 · Received September 20, 2023

    Report

    Report Number
    3007208013-2023-00044
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    May 1, 2023
    Report Date
    October 30, 2023
    Manufacturer
    SYMMETRY SURGICAL INC
    Product Code
    HXK
    UDI-DI
    00887482009727
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER NOTIFIED SYMMETRY ON 10/09/2023 THAT THE DEVICE WAS FOUND AND AVAILABLE FOR RETURNED. UPON RECEIVING THE DEVICE, IT WAS EVALUATED AND CONFIRMED TO HAVE A MANUFACTURED DATE OF 1410 ( OCT 2014). THE DEVICE SHOWED SIGNIFICANT SIGNS OF WEAR AND TEAR AND A DARD SPOT ON THE BREAK THAT INDICITIVE THAT THE JAW WAS CRACKED FOR SOMETIME BEFORE THE JAW BROKE OFF DURING THE PROCEDURE. THE CRACK COULD HAVE OCCURRED DURING ANOTHER CASE, OR IT COULD HAVE BEEN MISHANDLED DURING CLEANING. BASED ON THE PRODUCT REVIEW AND THE RISK ASSESSMENT NO FURTHER ACTIONS ARE NECESSARY. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMAITON PERTINENT TO THE INVESTIGATION, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS CONFIRMED VIA PICTURES PROVIDED BY THE CUSTOMER. HOWEVER, THE PICTURE PROVIDED DID NOT SHOW ANY OF THE MARKINGS ON THE DEVICE TO DETERMINE THE LOT NUMBER OF THE DEVICE. THE DEVICE WAS DISCARDED AFTER THE PICTURES WERE TAKEN. THEREFORE, THE DEVICE CANNOT BE RETURNED AND NO MORE PICTURES CAN BE TAKEN. WITHOUT FURTHER INFORMATION, A TRUE ROOT CANNOT BE DETERMINED. THE COMPLAINT HAS BEEN LOGGED IN THE COMPLAINT SYSTEM FOR TRACKING AND TRENDING. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF ALL LOTS WITH NO ADDITIONAL COMPLAINTS RECORDED FOR THE JAW BREAKING OFF. THEREFORE, THIS IS AN ISOLATED EVENT. RECEIVED VIA USER FACILITY REPORT# (B)(4)

    Description of Event or Problem · 0

    THE CUSTOMER ALLEGED THAT DURING A DECOMPRESSION POSTERIOR LUMBAR WITH FUSION EXTENSION TO L1 AND ANTERIOR LUMBAR INTERBODY FUSION WITH VASCULAR ASSIST, ONE SIDE OF THE JAWS BROKE OFF ENTIRELY. THE PIECE FELL INTO THE PATIENT AND WAS RETRIEVED WITH NO FURTHER HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802102 SYMMETRY NEEDLE HOLDER HXK SYMMETRY SURGICAL INC 1410 00887482009727

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown