BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JTS DRIVE UNIT

    MDR report key: 9937490 · Received April 8, 2020

    Report

    Report Number
    3004105610-2020-00080
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 11, 2020
    Report Date
    October 14, 2020
    Manufacturer
    STANMORE IMPLANTS WORLDWIDE
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS EVENT IS RELATED TO A JTS DRIVE UNIT WHICH IS USED IN CONJUNCTION WITH THE JTS NON-INVASIVE EXTENDIBLE IMPLANT (K092138) REPORTED EVENT: AN EVENT REGARDING A NON FUNCTIONING JTS DRIVE UNIT WAS REPORTED. THE EVENT WAS CONFIRMED BY PRODUCT INSPECTION. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION. PICTURES OF THE JTS POWER UNIT AND JTS COIL WERE TAKEN. VISUAL INSPECTION OF THE JTS COIL REPORTED MINOR SCRATCHES ON THE FRONTAL SIDE. THE JTS POWER UNIT DOES NOT SHOW DAMAGE ON THE EXTERNAL SURFACE. HOWEVER, THE PICTURE FROM THE FUNCTIONALITY TEST SHOWS THAT A LOOSE SCREW WAS RATTLING AROUND IN THE POWER UNIT. FUNCTIONAL INSPECTION: THE UNIT HAS FAILED THE IN HOUSE FUNCTIONALITY TEST. THE FIELD STRENGTH TEST WAS NOT PERFORMED AS IT WAS NOTICED DURING THE VISUAL INSPECTION THAT A LOOSE ITEM WAS RATTLING AROUND IN THE POWER UNIT. CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS OR X-RAY IMAGES WERE PROVIDED. PRODUCT HISTORY REVIEW: A REVIEW OF SIW DOCUMENTS REPORTED THAT JTS DRIVE UNIT 907-238 PASSED BOTH ANNUAL MAINTENANCE AND FUNCTIONALITY TEST ON 10JUN2019 AND 07AUG2019 RESPECTIVELY. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 7 OTHER EVENTS. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE JTS DRIVE UNIT WAS FAULTY. FOR THIS REASON, THE UNIT WILL BE SENT FOR REPAIR.

    Additional Manufacturer Narrative · 0

    UPDATED CONCLUSION: ADDITIONAL INFORMATION RECEIVED CONFIRMED THE PATIENT HAD A SUCCESSFUL LENGTHENING PROCEDURE USING A DIFFERENT JTS DRIVE UNIT. THE JTS DRIVE UNIT WAS RECEIVED BACK AFTER BEING REPAIRED. REPORTED EVENT: AN EVENT REGARDING A NON FUNCTIONING JTS DRIVE UNIT WAS REPORTED. THE EVENT WAS CONFIRMED BY PRODUCT INSPECTION. METHOD AND RESULTS: PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: PICTURES OF THE JTS POWER UNIT AND JTS COIL WERE TAKEN. VISUAL INSPECTION OF THE JTS COIL REPORTED MINOR SCRATCHES ON THE FRONTAL SIDE. THE JTS POWER UNIT DOES NOT SHOW DAMAGE ON THE EXTERNAL SURFACE. HOWEVER, THE PICTURE FROM THE FUNCTIONALITY TEST SHOWS THAT A LOOSE SCREW WAS RATTLING AROUND IN THE POWER UNIT. FUNCTIONAL INSPECTION: THE UNIT HAS FAILED THE IN HOUSE FUNCTIONALITY TEST. THE FIELD STRENGTH TEST WAS NOT PERFORMED AS IT WAS NOTICED DURING THE VISUAL INSPECTION THAT A LOOSE ITEM WAS RATTLING AROUND IN THE POWER UNIT. CLINICIAN REVIEW: NOT PERFORMED AS NO MEDICAL RECORDS OR X-RAY IMAGES WERE PROVIDED. PRODUCT HISTORY REVIEW: A REVIEW OF SIW DOCUMENTS REPORTED THAT JTS DRIVE UNIT 907-238 PASSED BOTH ANNUAL MAINTENANCE AND FUNCTIONALITY TEST ON 10JUN2019 AND 07AUG2019 RESPECTIVELY. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN 9 OTHER EVENTS. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE JTS DRIVE UNIT WAS FAULTY. FOR THIS REASON, THE UNIT WAS SENT FOR REPAIR. THE SERVICE REPORT WAS PROVIDED ON THE 04SEP2020, REPORTING THE FOLLOWING: "INVESTIGATION: UNIT HAS LOOSE SCREWS AND SCREEN HAD BROKEN OFF. RECTIFICATION: RETIGHTENED SCREWS THAT WAS LOOSE AND REPLACED BROKEN SCREEN. CHECKED ALL OTHER SCREWS TO MAKE SURE NONE WERE LOOSE OR BROKEN INSIDE THE UNIT." THE SALES REP REPORTED THAT THE PATIENT WAS SUCCESSFULLY EXTENDED WITH ANOTHER JTS DRIVE UNIT. NO FURTHER INFO WERE PROVIDED. SIW WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THIS PI IS FOR PATIENT NO 1: THE UNIT STOPPED AFTER 8 MINUTES. THEY TRIED TO REVERSE SEVERAL TIMES. AS REPORTED: "YESTERDAY, PERFORMED EXTENSION ON 3 PATIENTS, WHERE THE JTS UNIT DIDN¿T FUNCTION PROPERLY."

    Description of Event or Problem · 0

    THIS PI IS FOR PATIENT NO (B)(6): THE UNIT STOPPED AFTER 8 MINUTES. THEY TRIED TO REVERSE SEVERAL TIMES. AS REPORTED: "YESTERDAY, PERFORMED EXTENSION ON 3 PATIENTS, WHERE THE JTS UNIT DIDN¿T FUNCTION PROPERLY."

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS EVENT IS RELATED TO A JTS DRIVE UNIT WHICH IS USED IN CONJUNCTION WITH THE JTS NON-INVASIVE EXTENDIBLE IMPLANT (K092138). AN INVESTIGATION IS BEING PERFORMED IN AN ATTEMPT TO IDENTIFY THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THIS PI IS FOR PATIENT NO 1: THE UNIT STOPPED AFTER 8 MINUTES. THEY TRIED TO REVERSE SEVERAL TIMES. AS REPORTED: "YESTERDAY, PERFORMED EXTENSION ON 3 PATIENTS, WHERE THE JTS UNIT DIDN¿T FUNCTION PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403926 JTS DRIVE UNIT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STANMORE IMPLANTS WORLDWIDE 907-238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other