BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5245542 · Received November 24, 2015

    Report

    Report Number
    3009450884-2015-10079
    Event Type
    Injury
    Date Received
    November 24, 2015
    Report Date
    November 5, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    KTT
    PMA / PMN Number
    PK000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. THE FOLLOWING PARTS WERE RECEIVED; IT IS UNKNOWN WHICH WAS THE COMPLAINED SCREW: PART 213.014, LOT 9277981 3.5MM LOCKING SCREW SELF-TAPPING 14MM; PART 213.022, LOT 9231480 3.5MM LOCKING SCREW SELF-TAPPING 22MM; PART 213.020, LOT 9085917 3.5MM LOCKING SCREW SELF-TAPPING 20MM; 2 - PART 213.022, LOT 9340205 3.5MM LOCKING SCREW SELF-TAPPING 22MM; PART 213.024, LOT 9344424 3.5MM LOCKING SCREW SELF-TAPPING 24MM; SINCE IT IS UNKNOWN WHICH SCREW WAS INVOLVED, THE UDI NUMBER IS UNKNOWN. (B)(6). (B)(4). PART 213.014, LOT 9277981: MANUFACTURING DATE: 26NOVEMBER2014; PART 213.022, LOT 9231480: MANUFACTURING DATE: 28OCTOBER2014; PART 213.020, LOT 9085917: MANUFACTURING DATE: 25JULY2014; PART 213.022, LOT 9340205: MANUFACTURING DATE: 20JANUARY2015; PART 213.024, LOT 9344424: MANUFACTURING DATE: 21JANUARY2015. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL POTENTIAL PART/LOTS WAS COMPLETED: NO NON-CONFORMANCE REPORTS 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. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE SCREWS WERE RECEIVED AND ARE INTACT AND THEY DO NOT SHOW WEAR OR DAMAGE. ALL DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. THE INVESTIGATION APPROVES THAT THE PLATE BROKE BECAUSE OF MECHANICAL OVERLOADING. THE SCREWS ARE INTACT AND CONCOMITANT DEVICES. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A BROKEN PLATE INCIDENT OCCURRED. THE FIRST OPERATION WAS DONE ON (B)(6) 2015. THE PLATE BROKE IN (B)(6) 2015; THIS WAS CONFIRMED BY X-RAY. THE SECOND OPERATION WAS DONE ON (B)(6) 2015 TO REMOVE THE BROKEN IMPLANT. REVISION SURGERY DONE WITH LOCKING COMPRESSION PLATE (LCP) 3.5MM EXTRA ARTICULAR DISTAL HUMERUS PLATE. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775865 APPLIANCE, FIXATION, NAIL KTT SYNTHES GRENCHEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention