BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 3121541 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02731
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K103243
    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. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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

    ADDITIONAL NARRATIVE: AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT THE MEASURABLE DIMENSIONS OF THE BROKEN VA LOCKING SCREWS STARDRIVE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE LOT NUMBERS ARE NOT KNOWN, THEREFORE THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS CANNOT BE REVIEWED AND THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. WE CAN ONLY CONFIRM THAT OUR VA LOCKING SCREWS MADE FROM TITANIUM ALLOY ARE MANUFACTURED IN COMPLIANCE WITH THE AO/ASIF SPECIFICATION. UNFORTUNATELY, THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE ADDITIONAL EVALUATION REPORTS AS RECEIVED CONDITION TO BE A BREAKAGE OF THREE VA LOCKING SCREWS. THE MEASURABLE DIMENSIONS OF THE BROKEN VA LOCKING SCREWS STARDRIVE WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE LOT NUMBERS ARE NOT KNOWN, THEREFORE THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING DOCUMENTS CANNOT BE REVIEWED AND THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. WE CAN ONLY CONFIRM THAT OUR VA LOCKING SCREWS MADE FROM TITANIUM ALLOY ARE MANUFACTURED IN COMPLIANCE WITH THE AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-11. UNFORTUNATELY THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED. THE DISPOSITION OF THIS EVALUATION IS DEEMED INVALID.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON EXPERIENCED BREAKAGE OF THREE 2.4 SCREWS IN A DISTAL RADIUS PLATE. 5 SCREWS WERE IN THE DISTAL ROW. IT IS UNKNOWN WHEN THIS EVENT OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224711 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention