BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L16 TAN

    MDR report key: 2850019 · Received November 29, 2012

    Report

    Report Number
    8030965-2012-01395
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    October 31, 2012
    Report Date
    October 31, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K102694
    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 MANUFACTURING EVALUATION WAS CONDUCTED AND THE REPORT INDICATES: A SINGLE SCREW WAS RECEIVED AND APPEARED TO BE INTACT. THE SCREW DIMENSIONS WERE MEASURED, AND IT WAS CONFIRMED THIS WAS THE SCREW ASSOCIATED WITH AND DESCRIBED FROM THE EVENT. THE DRIVE HAS SLIGHT MARKINGS CONSISTENT WITH USE. THE TOP OF THE HEAD HAS SLIGHT DAMAGE IN THE FORM OF RAISED MATERIAL AT THE JUNCTURE OF THE HEAD THREAD. THE HEAD THREADS HAVE BEEN SLIGHTLY COMPRESSED AT THE MAJOR DIAMETER WITH THE CREST OF THE THREAD FOLDED SLIGHTLY UPWARDS TOWARDS THE TOP OF THE HEAD. THE FINISH HAS BEEN REMOVED IN THIS AREA. THE FIRST SHAFT THREAD HAS A SMALL DENT WITH DISPLACE MATERIAL. THE REMAINDER OF THE SHAFT THREADS ARE IN GOOD CONDITION, AS ARE THE FLUTES AND THE TIP. THE RELEVANT DIMENSIONS THAT COULD BE CHECKED ARE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE TOP OF THE HEAD HAS SLIGHT DAMAGE IN THE FORM OF RAISED MATERIAL AT THE JUNCTURE OF THE HEAD THREAD. THE HEAD THREADS HAVE BEEN SLIGHTLY COMPRESSED AT THE MAJOR DIAMETER WITH THE CREST OF THE THREAD FOLDED SLIGHTLY UPWARDS TOWARDS THE TOP OF THE HEAD. WE COULD NOT DETERMINE THE EXACT ROOT CAUSE FOR THIS KIND OF DAMAGE. THE RELEVANT DIMENSIONS THAT COULD BE CHECKED ARE WITHIN THE SPECIFICATIONS. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THIS IS 2 OF 2 REPORTS FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A DISTAL RADIUS FRACTURE PROCEDURE, AFTER REPOSITIONING AND IMPLANTING THE PLATE, THE SURGEON THEN INSERTED THE CORTEX SCREW IN A POSITIONING HOLE AT THE SHAFT. WHILE THE SURGEON WAS INSERTING THE VA LOCKING SCREW INTO THE MOST DISTAL HOLE IN THE FIRST ROW AT THE ULNAR SIDE OF THE PLATE WITH THE TORQUE LIMITING DRIVER USING A GUIDING BLOCK BY A FIXED-ANGLE PROCEDURE, THE LOCKING SCREW WENT THROUGH THE PLATE. THIS EVENT WAS NOTED WHILE VIEWING THE X-RAY. THE SURGEON REMOVED THE PLATE AND SCREWS AND REPLACED THE PLATE WITH ANOTHER SIZED PLATE. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA LOCKSCR Ø2.4 SELF-TAP L16 TAN LOCKING SCREW HWC SYNTHES GMBH 8079903

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention PLATE