BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 38MM

    MDR report key: 3895956 · Received June 26, 2014

    Report

    Report Number
    3003875359-2014-10186
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE DEVICE HISTORY RECORD REVIEW REVEALED THAT THE MEASURABLE DIMENSIONS OF THE RETURNED FLEXIBLE SHAFT WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE 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 ISO (B)(4). NO PRODUCT FAULT COULD BE DETECTED. THE MICROSCOPIC VIEW OF THE BROKEN SURFACE DOES NOT SHOW ANY ANOMALIES OF MATERIALS STRUCTURE. THE ARTICLE/LOT IN QUESTION WAS PRODUCED IN A QUANTITY OF (B)(4) PIECES. ALL OF THEM WERE ALREADY DISTRIBUTED WORLDWIDE. WE ARE NOT AWARE OF ANY OTHER SIMILAR COMPLAINTS. MANUFACTURING AND INSPECTION RECORDS INDICATE NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THE AVAILABLE INFORMATION IT APPEARS THAT TOO HIGH MECHANICAL FORCE HAD BEEN APPLIED AND RESULTED IN THE BREAKAGE. 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. ADDITIONAL COMMON DEVICE NAMES; KTT, HRS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NONCONFORMANCE 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. 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 SURGERY TO IMPLANT AN LCP PLATE AND DYNAMIC HIP SYSTEM A SCREW BROKE. THE SURGEON WAS ONLY ABLE TO REMOVE HALF THE SCREW THE REST REMAINS IN THE PATIENT. THE EVENT PROLONGED THE SURGERY APPROXIMATELY 20 MINUTES. THE PATIENT IS REPORTED TO BE DOING FINE AND HAS BEEN DISCHARGED FROM THE HOSPITAL THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375188 4.5MM TI CORTEX SCREW SELF-TAPPING 38MM SCREW, FIXATION, BONE HWC SYNTHES HAGENDORF 8562063

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR