BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 36MM

    MDR report key: 4782079 · Received May 19, 2015

    Report

    Report Number
    3009450884-2015-10042
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    May 5, 2014
    Report Date
    May 27, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS INITIALLY SUBMITTED UNDER MFR NUMBER 3009450884-2014-10025 AS AN INITIAL MEDWATCH (SUBMITTED JUNE 25, 2014) AND TWO FOLLOW UP MEDWATCH (SUBMITTED SEPTEMBER 12, 2014); HOWEVER, IT WAS NOTED ON MAY 08, 2015 THAT THE INITIAL MEDWATCH HAD FAILED THE SUBMISSION PROCESS DUE TO AN ISSUE. INFORMATION IS BEING RESUBMITTED UNDER THIS NEW MFR NUMBER TO ENSURE DELIVERY TO THE FDA. PATIENT INFORMATION IS UNKNOWN. IMPLANT AND EXPLANT DATES: DEVICE BROKE DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. INITIAL REPORTER: CITY: (B)(6). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING EVALUATION WAS COMPLETED: THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE SCREW HEAD WAS SEND BACK, CLEARLY VISIBLE TRACES OF EXCESSIVE USE. THE MEASURABLE DIMENSIONS OF THE RECEIVED CORTEX SCREW FRAGMENT WERE AS FAR AS POSSIBLE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD FOR UNALLOYED TITANIUM (ISO 5832-2). THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. NO PRODUCT FAULT COULD BE DETECTED. THE INVESTIGATION FOUND THAT THE REMAINING THREAD FLANK BELOW THE SCREW HEAD IS TOTALLY FLATTENED AND THERE ARE STRONG STRESS MARKS AT THE BOTTOM OF THE SCREW HEAD VISIBLE. THE ANODIZATION LAYER IS WORN OUT AT THE DAMAGES, WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING. THE KIND OF THE DAMAGE IS LIKELY THE RESULT OF EXCESSIVE METALLIC CONTACT DURING THE INSERTION, PAR EXAMPLE WITH THE PLATE, CAUSED A MECHANICAL OVERLOAD AND FINALLY THE BREAKAGE OF THE SCREW. 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: DURING THE SCREWING OF A SCREW, THE SCREW HEAD BROKE IN THE SITU. THE SCREW HEAD WAS BACKED OUT; HOWEVER, THE SCREW SHAFT REMAINED IN THE SITU. NO CONSEQUENCE TO THE PATIENT, DELAY OF SURGERY WAS LESS THAN 15 MINUTES; THE INCIDENT DID NOT REQUIRE ANY FURTHER TREATMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326867 4.5MM TI CORTEX SCREW SELF-TAPPING 36MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 8718283

    Patients

    Seq Age Sex Outcome Treatment
    1