BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM

    MDR report key: 5766057 · Received July 1, 2016

    Report

    Report Number
    3009450884-2016-10083
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    April 19, 2016
    Report Date
    April 20, 2016
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    KTT
    PMA / PMN Number
    PK023941
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT PROVIDED FOR REPORTING. DATE EVENT FIRST REPORTED WAS 20APR2016, UNKNOWN WHEN ACTUAL BREAKAGE OCCURRED. ORIGINAL IMPLANT DATE APR 19, 2016. CONCOMITANT PRODUCTS: (15) CONCOMITANT DEVICES REPORTED. (B)(6). THIS EVENT RESULTED IN THE NEED FOR ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE BROKEN IMPLANT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 14 SEPTEMBER 2015, 413.340 / LOT: 9651961. 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.

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF DEVICE BREAKAGE IS UNKNOWN. CLARIFICATION: THE MANUFACTURER WAS ORIGINALLY AWARE OF AN INCIDENT ON (B)(6) 2016; HOWEVER, THIS PART¿S INVOLVEMENT IN THE EVENT WAS NOT KNOWN UNTIL (B)(6) 2016. THEREFORE, SHOULD REFLECT (B)(6) 2016 AND (ON THE INITIAL MEDWATCH) SHOULD REFLECT (B)(6) 2016. THE ORIGINAL IMPLANT PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE. DEVICE 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE BROKEN PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL PACKAGING. THE LASER ETCHING WAS READABLE. THERE WERE USAGE MARKS/ OBVIOUS DISCOLORATIONS ON DIFFERENT AREAS VISIBLE. BOTH PIECES (HEAD AND SHAFT) OF THE BROKEN PRODUCT WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL RELEVANT DIMENSIONS FOR THE FUNCTION OF THE PRODUCT WERE MEASURED, AND FULFILL THE SPECIFICATIONS. IN ADDITION THE MATERIAL CERTIFICATE WAS ALSO CHECKED AND FULFILLS THE SPECIFICATION. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE MANUFACTURING POINT OF VIEW. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLATE BROKE POST-OPERATIVELY, BOTH LEFT AND RIGHT PLATES WERE BROKEN AT THE SAME TIME IN THE SAME PATIENT WHILE COMING DOWN FROM THE STAIRS. THE PLATE BROKE AT AN OCCUPIED SCREW HOLE. REVISION SURGERY HAS BEEN PERFORMED. PATIENT IS STABLE. 16JUNE 16: MATERIAL RECEIVED: 2 BROKEN PLATES AND ONE BROKEN SCREW. THIS COMPLAINT INVOLVES 3 PARTS: 440.831 / 9536288 / 1 / BROKEN PLATE - NON-REPORTABLE; 440.831 / 9232106 / 1 / BROKEN PLATE; 413.340 / 9651961 / 1 / BROKEN SCREW. CONCOMITANT PARTS: 413.328 / 9606999 / 1 / INTACT; 413.350 / 9701444 // 1 / INTACT; 413.336 / 9353941 / 1 / INTACT; 413.336 / 9636607 / 1 / INTACT; 413.355 / 9708150 / / 1 / INTACT; 413.350 / 9701444 / 1 / INTACT; 413.330 / 9680623 / 1 / INTACT; 413.334 / 9708946 / 1 / INTACT; 413.346 / 8916857 / 1 / INTACT; 413.330 / 9686051 / 1 / INTACT; 413.338 / 9662122 / 1 / INTACT; 413.346 / 8227378/ 1 / INTACT; 413.355 / 9708150 / 1 / INTACT; 413.342 / 8795886 / 1 / INTACT; 413.332 / 9678095 / 1 / INTACT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION: IT WAS FURTHER REPORTED THAT TWO (2) PLATES, BOTH LEFT AND RIGHT, AND ONE (1) SCREW BROKE POST-OPERATIVELY. IT WAS NOTED THAT THE PLATE BREAKAGE OCCURRED AT AN OCCUPIED SCREW HOLE. CLARIFICATION WAS ALSO RECEIVED AROUND THE REVISION/EXPLANT DATE, WHICH WAS ORIGINALLY REPORTED AS (B)(6) 2016. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT THE REVISION WAS PERFORMED ON (B)(6) 2016. CONCOMITANT DEVICE(S) REPORTED: 5.0MM TI LOCKING SCREW (PART: 413.328 / LOT: 9606999 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.350 / LOT: 9701444 / QUANTITY: 2), 5.0MM TI LOCKING SCREW (PART: 413.336 / LOTS: 9353941 AND 9636607/ QUANTITY: 1 OF EACH LOT), 5.0MM TI LOCKING SCREW (PART: 413.355 / LOT: 9708150 / QUANTITY: 2), 5.0MM TI LOCKING SCREW (PART: 413.330 / LOTS: 9680623 AND 9686051 / QUANTITY: 1 OF EACH), 5.0MM TI LOCKING SCREW (PART: 413.334 / LOT: 9708946 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.346 / LOTS: 8916857 AND 8227378 / QUANTITY: 1 OF EACH), 5.0MM TI LOCKING SCREW (PART: 413.338 / LOT: 9662122 / QUANTITY: 1), 5.0MM TI LOCKING SCREW (PART: 413.342 / LOT: 8795886 / QUANTITY: 1), AND 5.0MM TI LOCKING SCREW (PART: 413.332 / LOT: 9678095 / QUANTITY: 1). THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419808 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM APPLIANCE,FIXATION,NAIL KTT SYNTHES GRENCHEN 9651961

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention