BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 28MM

    MDR report key: 6542807 · Received May 3, 2017

    Report

    Report Number
    2520274-2017-11588
    Event Type
    Injury
    Date Received
    May 3, 2017
    Report Date
    April 7, 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

    ADDED LOT NUMBER FOR CONCOMITANT PLATE (441.919) A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 413.028-CX, LOT # 9519373: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 08.JUNE.2015: NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE RECEIVED PARTS (441.919 / 9923080, 413.026 / L084001, 413.028 / 9519373, 404.826 / 9060469) WERE FORWARDED TO THE RESPONSIBLE PERSON IN THE SUSTAINING ENGINEERING DEPARTMENT FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS IDENTIFIED THAT THE PLATE IS CLEAN AND NOT BROKEN, AND THE SCREWS ARE CLEAN AND BROKEN, THIS THUS CONFIRMS THE COMPLAINT DESCRIPTION. AS THE RETURNED PLATE DOESN¿T SHOW ANY ABNORMAL WEAR TRACES AND ONLY THE RETURNED SCREWS ARE BROKEN, THE PLATE WON¿T BE CONSIDERED IN THIS EVALUATION EVEN THOUGH IT HAS BEEN RETURNED. AS THE SCREWS HAVE THE SAME FUNCTION OF STABILIZATION OF THE PLATE / BONE SYSTEM THE ANALYSIS CONSIDER BOTH SCREW FAMILIES (LCP & CORTEX) REGARDLESS OF THEIR USE AND DRIVE GEOMETRY (HEX & STARDRIVE). AS THE MATERIAL OF THE SCREW (TITANIUM VS. STEEL) DOES IMPACT THE STRENGTH OF THE SCREW ONLY THE TITANIUM SCREWS HAVE BEEN CONSIDERED. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE. 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 USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    CONCOMITANT PART REPORTED: PLATE (PART # 441.919, LOT # 9923080, QUANTITY 1)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2017 WITH HISTORY OF FALL FROM STAIRS. CLINICAL AND RADIOLOGICAL EXAMINATION SHOWED COMMINUTED FRACTURE OF THE PROXIMAL 1/3RD OF RIGHT HUMERUS. PATIENT WAS OPERATED ON (B)(6) 2017 AND OPEN REDUCTION AND INTERNAL FIXATION WITH 7 HOLE AO PHILOS PLATE WITH 2 INTERFRAGMENTARY SCREWS WAS DONE. POST OPERATIVE PERIOD WAS UNEVENTFUL. APPROX 3 WEEKS POSTOPERATIVELY, ACTIVE ASSISTED MOBILIZATION OF RIGHT SHOULDER AND ELBOW WAS STARTED. CHECK X-RAYS AT 6 WEEKS WERE SATISFACTORY. HOWEVER, AT 2 MONTHS PATIENT PRESENTED WITH IMPLANT FAILURE WITHOUT ANY HISTORY OF TRAUMA. PATIENT DOES NOT HAVE ANY COMORBIDITY ALL THROUGH THE COURSE OF THE TREATMENT AND THERE ARE NO SIGNS OF INFECTION. ALSO REPORTED WAS ORIF WITH 2 INTERFRAGMENTARY SCREWS WITH PHILOS DONE, THE PROCEDURE WAS SUCCESSFUL, HOWEVER, BROKEN FRAGMENTS WERE REMOVED WITH DIFFICULTY WHICH REQUIRED ADDITIONAL INTERVENTION (2) SCREWS (LOCKING), AND (1) CORETEX. THE SURGERY WAS DONE 2 MONTHS BEFORE BUT THE SCREWS BROKE INSIDE THE PLATE AND PATIENT PRESENTED WITH BROKEN SCREWS INSIDE AND AFTER 2 MONTHS, THE SURGERY WAS PERFORMED AGAIN WITH THE IMPLANT REMOVAL AND UHN NAIL DONE WITH ENCERCLAGE WIRING AND BONE GRAFTING. DUE TO THIS NON UNION, DELAYED HEALING, THE EXPLANT DATE WAS (B)(6) 2017. THIS COMPLAINT INVOLVES THREE PARTS. CONCOMITANT MEDICAL PRODUCTS: 1X PLATE 441.919, LOT UNK; 1X 404.828 CORTEX SCREW, LOT UNK. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323269 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM APPLIANCE,FIXATION,NAIL KTT JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 9519373

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 1X 404.828 CORTEX SCREW, LOT UNK