BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/ 2H SHAFT / LT-STER

    MDR report key: 3662312 · Received March 6, 2014

    Report

    Report Number
    1000562954-2014-10004
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 15, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK092556
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2014, THE VARIABLE ANGLE LOCKING COMPRESSION PLATE WAS USED FOR A FRACTURE OF DISTAL RADIUS. AFTER USING THE GUIDING BLOCK, THE CORTEX SCREW WAS INSERTED INTO THE COMBINATION HOLE, THE SCREW WAS INSERTED FROM DISTAL SIDE TO RADIUS SIDE. DURING THE SCREW INSERTION OF MOST OF THE DISTAL RADIUS SIDE, THE SCREW WOULD NOT LOCK AT ALL. THE DOCTOR THEN CHECKED BY IMAGE, AND THEN FOUND OUT THAT THE SCREW PENETRATED. THE DOCTOR REMOVED THE SCREW FROM THE DORSAL PART. IT WAS REPORTED THAT DURING THE SCREW INSERTION, THE SURGEON DID NOT HEAR THE CLICK SOUND FROM THE TORQUE LIMITING ATTACHMENT. WHEN THE SURGEON TRIED TO TURN THE DEVICE MOREOVER, IT WENT THROUGH THE PLATE WITH THE METALLIC FRAGMENT IN QUESTION. THE SURGEON CLOSED A SURGICAL INCISION WITHOUT THE SCREW INSERTION INTO THE AFFECTED PLATE HOLE. THIS REPORT IS FOR 1 OF 1 COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THERE WAS A 15 MINUTE DELAY AND NO PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135092 2.4MM TI VA-LCP 2-COL DSTL RAD PL NRW 6H HD/ 2H SHAFT / LT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8558769

    Patients

    Seq Age Sex Outcome Treatment
    1