BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP® PLATE 12 HOLES 163MM

    MDR report key: 6337615 · Received February 16, 2017

    Report

    Report Number
    3009417901-2017-10004
    Event Type
    Injury
    Date Received
    February 16, 2017
    Report Date
    January 23, 2017
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD.
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE ON X-RAYS WAS REPORTED AS 77, 75, 76 YEARS; IT IS UNKNOWN WHICH IS CORRECT. A MANUFACTURING EVALUATION AND PRODUCT INVESTIGATION WERE COMPLETED: THE DEVICE WAS RECEIVED BROKEN. AFTER REVIEWING THE DEVICE HISTORY RECORD, IT CAN BE CONCLUDED THAT ALL THE INSPECTION MEET THE TOP LEVEL DRAWING REQUIREMENT, THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL MEET PER ACCEPT CRITERIA; THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES DURING THE MANUFACTURING PROCESS. THE RETURNED DEVICE WAS RE-INSPECTED AND THE MEASUREMENTS AND HARDNESS MEET THE TOP LEVEL DRAWING REQUIREMENT. THE FAILURE MODE COULD NOT BE CONFIRMED DUE TO NOT HAVING OTHER PRODUCTS AVAILABLE FROM THIS LOT TO REVIEW. THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE MANUFACTURING POINT OF VIEW. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. THE RETURNED CONCOMITANT DEVICES WERE INSPECTED AND IT WAS DETERMINED THEY ARE NOT RESPONSIBLE FOR THE BREAKAGE OF THE PLATE. THE PROVIDED X-RAYS WERE REVIEWED BY THE MANUFACTURER, BUT THE PLATE BREAKAGE COULD NOT BE CONFIRMED ON THEM. NO PRODUCT FAULT COULD BE DETECTED. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR 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 · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CORRECTED DATA: 3.5MM TI LCP® PLATE 12 HOLES 163MM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ORIGINAL IMPLANT DATE WAS 4-5 DAYS BEFORE THE PLATE BROKE. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: 423.621 LOT. 9811674 MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 25.JAN.2016 . NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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 · 1

    UPDATE CONCOMITANT PARTS REPORTED: CORTEX SCREW (PART 404.822, LOT 9896129, QUANTITY 1); CORTEX SCREW (PART 404.828, LOT 9852777, QUANTITY 2); CORTEX SCREW (PART 404.826, LOT 9875506, QUANTITY 1); CORTEX SCREW (PART 404.828, LOT L079029, QUANTITY 1); CORTEX SCREW (PART 404.824, LOT 8972860, QUANTITY 1); LOCKING SCREW (PART 413.022, LOT L050476, QUANTITY 1); LOCKING SCREW (PART 413.024, LOT L061023, QUANTITY 1); NON-SYNTHES SCREW (PART/LOT UG1747 AHI 024, QUANTITY 1).

    Description of Event or Problem · 1

    THE DOCTOR USED 3.5 LCP 12 HOLE PLATE WITH ONE 2.7 INTERFRA SCREWS WITH OUR 3.5 LOCKING AND CORTICAL SCREWS. AFTER OPERATING IN NEXT FOUR DAYS PLATE GOT BROKEN. AFTER THIS HE OPERATED SAME PATIENT WITH OUR 4.5 LCP NARROW.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A LCP PLATE WAS BROKEN AFER 5 DAYS OF SURGERY. THIS IS ALL INFORMATION AVAILABLE TO DATE. CONCOMITANT PARTS REPORTED: 1X 404.822 LOT. 9896129 CORTEX SCREW; 1X 404.828 LOT. 9885412 CORTEX SCREW; 4X UNKNOWN CORTEX SCREW, UNKNOWN LOT; 1X 413.022 LOT. L079028 LOCKING SCREW; 1X 413.024 LOT. 9846021 LOCKING SCREW; 1X UNKNOWN LOCKING SCREW, UNKNOWN LOT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119470 3.5MM TI LCP® PLATE 12 HOLES 163MM APPLIANCE,FIXATION,NAIL KTT JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 9811674

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1X 404.822 LOT. 9896129 CORTEX SCREW| 1X 404.828 LOT. 9885412 CORTEX SCREW| 1X 413.022 LOT. L079028 LOCKING SCREW| 1X 413.024 LOT. 9846021 LOCKING SCREW| 1X UNKNOWN LOCKING SCREW, UNKNOWN LOT| 4X UNKNOWN CORTEX SCREW, UNKNOWN LOT