BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 38MM

    MDR report key: 4630610 · Received March 25, 2015

    Report

    Report Number
    3009450884-2015-10025
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Report Date
    March 10, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. A PRODUCT INVESTIGATION WAS COMPLETED: WE HAVE RECEIVED THESE ARTICLES 04.224.224, 480.990S, 480.900, 414.834 BACK IN AN INTACT CONDITION. OUR INVESTIGATION OF THE COMPLAINED IMPLANTS HAS SHOWN: THAT THE ARTICLES 414.838, 414.838, 414.836 WE HAVE RECEIVED BACK BROKEN / BADLY DAMAGED AND ONE WITH BONE ADHERED. ALSO THERE ARE SCRATCHES ON THE SURFACE AND DEFORMATION AT SHANK AND AT THE THREAD VISIBLE. THIS INDICATES CONTACT WITH THE PLATE. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS REPORTED PROBLEM, BUT IT IS LIKELY THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE OR THAT AN OVERLOADING SITUATION OR STRONG BODY / BONE MOVEMENT FROM THE PATIENT LED TO THESE BREAKAGES OF THE SCREWS. THE MANUFACTURING RECORDS WERE REVIEWED THE IMPLANTS WERE MANUFACTURED IN (04.224.224, 8612986, SEPTEMBER 2013; 480.990S, 8753610, DECEMBER 2013; 480.900, 8903215, MAY 2014; 414.834, 8633444, SEPTEMBER 2013; 414.838, 2452548, JANUARY 2009; 414.838, 9019617, JUNE 2014; 414.836, 8590497, AUGUST 2013), PRODUCED TO SPECIFICATION AND MET ALL RELEASE CRITERIA. NO PRODUCT FAULT COULD BE DETECTED. 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

    DATE OF EVENT: UNKNOWN. (B)(4). 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 HAS BEEN REQUESTED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED THREE CORTEX SCREWS WERE FOUND BROKEN POST-OPERATIVELY. THE REPORTED PRODUCTS WERE USED FOR FEMORAL TROCHANTERIC FRACTURE. THE INITIAL IMPLANT DATE WAS (B)(6) 2014. THE SURGERY OF EXPLANT AND RE-FIXATION WITH ANOTHER MANUFACTURING¿S PRODUCTS WAS PERFORMED ON (B)(6) 2015. VARUS DEFORMITY WAS CONFIRMED AFTER THE INITIAL SURGERY. IT WAS REPORTED THE PLATE WAS NOT BROKEN. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199489 4.5MM TI CORTEX SCREW SELF-TAPPING 38MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 9019617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention