BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM¿STERILE

    MDR report key: 5367166 · Received January 14, 2016

    Report

    Report Number
    3000270450-2016-10015
    Event Type
    Injury
    Date Received
    January 14, 2016
    Date of Event
    December 25, 2015
    Report Date
    December 25, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK100776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: HEAVILY DAMAGED SCREW HEAD WAS RETURNED. THE VISUAL INSPECTION HAS SHOWN THAT THE RETURNED SCREW HEAD IS BADLY DAMAGED; NO MEASUREMENT COULD BE TAKEN DUE TO THE DEVICE CONDITION. THE SCREW RECESS GROUND IS BROKEN OPEN WITH HEAD THREAD PITCHES THAT ARE STRONGLY WORN DOWN AND SQUASHED. UNFORTUNATELY, THE BROKEN PART OF THE SCREW REMAINED IN PATIENT¿S BODY AND COULD NOT BE SENT TO US FOR INVESTIGATION. IT IS LIKELY THAT TOO MUCH FORCE WAS APPLIED TO THIS SCREW WHILE INSERTING AND DURING REPOSITIONING, WHICH LED TO THE BREAKAGE. NO MANUFACTURING RELATED FAILURE WAS FOUND. NO NON-CONFORMANCE REPORTS 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. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE SUBJECT DEVICE WAS NOT CONSIDERED TO BE IMPLANTED AS IT WAS REPORTEDLY BROKEN AND MAY NOT PERFORM ITS INTENDED FUNCTION. THE SUBJECT DEVICE (SCREW HEAD PORTION ONLY) IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. (B)(6). DEVICE HISTORY RECORD REVIEWS WERE PERFORMED FOR BOTH THE STERILIZATION AND THE MANUFACTURE OF THE SUBJECT DEVICE LOT. THE SUBJECT DEVICE WAS INITIALLY MANUFACTURED AS NON-STERILE LOT NUMBER 7830975. THE REVIEWS SHOWED THAT THERE WERE NO ISSUES DURING THE STERILIZATION OR MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    SYNTHES (B)(4) REPORTED EVENTS IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE TO TREAT AN INTRA ARTICULAR FRACTURE OF THE DISTAL HUMERUS ON (B)(6) 2015, A VARIABLE ANGLE (VA) LOCKING SCREW BROKE AT THE SCREW HEAD DURING TIGHTENING. THE SURGEON OPTED TO LEAVE THE BROKEN PORTION OF THE SCREW SHAFT IN THE PATIENT'S BONE. THE EVENT OCCURRED AFTER PLATE FIXATION WAS COMPLETED. THE SURGEON FOUND THAT THE REPORTED VA LOCKING SCREW IN QUESTION WAS OUT OF BOUND (OUT OF POSITION). THEREFORE, THE SURGEON REMOVED THE SCREW ONCE AND REINSERTED IT USING POWER TOOL WITH THE IMAGE INTENSIFIER. THE LOCKING SCREW WAS THEN INSERTED USING A POWER TOOL UNTIL THE SCREW HEAD WAS APPROXIMATELY 10MM FROM THE SURFACE OF THE SCREW HOLE. AT THIS POINT THE SURGEON CHECKED THE POSITION OF THE SCREW WITH THE IMAGE INTENSIFIER AGAIN AND THEN PROCEEDED WITH FURTHER INSERTION MANUALLY. WHEN THE SURGEON FINALLY ATTEMPTED TO TIGHTEN THE LOCKING SCREW USING TORQUE LIMITER MANUALLY, THE LOCKING SCREW WAS BROKE OFF AT THE SCREW HEAD. THERE WAS NO REPORT OF SURGICAL DELAY DUE TO THE REPORTED EVENT. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26377 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 46MM¿STERILE PLATE, FIXATION, BONE HRS SYNTHES SELZACH 9273429

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention