BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE

    MDR report key: 8568388 · Received May 1, 2019

    Report

    Report Number
    1030489-2019-00505
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 4, 2019
    Report Date
    October 27, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UPDATE PRODUCT INFORMATION E1, E4: UPDATED HCP INFORMATION G1, G2: UPDATED MANUFACTURER INFORMATION H3: PRODUCT ANALYSIS :PART # 803-290, LOT # SW13JE003- VISUAL AND OPTICAL INSPECTION REVEALED THE TIP OF THE PROBE HAS BROKE OFF. OPTICAL INSPECTION OF THE FRACTURE SURFACE REVEALED A FAIRLY BRITTLE AND RIGID FRACTURE SURFACE. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. H6: ANALYSIS RESULTED IN CHANGE IN EVAL. CODE METHOD, EVAL. CODE RESULT, AND EVAL. CODE CONCLUSION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OP, WHILE THE SURGEON WAS USING THE T-HANDLE PROBE, IT BENT AND THE TIP BROKE OFF IN THE PATIENT'S PEDICLE. THE BROKEN TIP WAS EVENTUALLY REMOVED FROM THE PEDICLE; AND THERE WERE NO FRAGMENT OF THE BROKEN INSTRUMENT REMAINING INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364277 PROBE PROBE HXB MEDTRONIC SOFAMOR DANEK USA, INC 803-290 SW13E003

    Patients

    Seq Age Sex Outcome Treatment
    1