BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LOCKING SCREW SELF-TAPPING 40MM

    MDR report key: 3223684 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04281
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE ADDITIONAL EVALUATION FOUND THAT THE MEASURABLE DIMENSION WERE 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. BASED ON THE PROVIDED DETAILS WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE. THIS IS LIKELY THE RESULT OF FAR TOO MUCH MECHANICAL FORCE DURING REMOVAL. THE MICROSCOPIC VIEW OF THE BROKEN SURFACES DUE NOT SHOW ANY ANOMALIES OF MATERIAL STRUCTURE, WHICH INDICATES MATERIAL CONFORMITY AS WELL. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: WHILE TRYING TO REMOVE THE PLATE FROM THE PATIENT WITH SIX MONTHS NON-UNION DISTAL MEDICAL FRACTURE, THE LOCKING SCREWS BROKE FROM THE NECK OF THE SCREWS. THERE WERE THREE BROKEN SCREWS. THE PLATE WAS NOT BROKEN. NO XRAY WAS TAKEN BEFORE THE PROCEDURE. THE PATIENT WAS COMPLAINING OF PAIN THAT IS WHY THE SURGEON DECIDED TO REMOVE THE PLATE AND LOOKED FOR ANOTHER SOLUTION. THE PATIENT DETAILS WERE NOT GIVEN BECAUSE OF THE RESTRICTION IN THE MILITARY HOSPITAL. IF FURTHER DETAILS ARE NEEDED, THE SURGEON CAN BE CONTACTED. INVOLVED ARTICLES: 1X DMT PLATE 439.901 LOT. 3801008, 2X SCREW 413.040 LOT. 7812930 BROKEN, 1X SCREW 406.045 LOT. 3802833. MATERIAL RECEIVED ON (B)(4) 2013. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323647 3.5MM TI LOCKING SCREW SELF-TAPPING 40MM KTT SYNTHES GMBH 7812930

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention