BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST

    MDR report key: 3891088 · Received June 24, 2014

    Report

    Report Number
    2520274-2014-12128
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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: IT WAS REPORTED THAT THE CONDYLAR STABILIZING TECHNIQUE WITH THE VARIABLE ANGLE LOCKING COMPRESSION PLATE AND LOCKING SCREW WAS PERFORMED FOR DISTAL RADIUS FRACTURE. AFTER PLACEMENT OF THE PLATE, THE LOCKING SCREW WAS INSERTED INTO THE MOST DISTAL HOLE WITH A TORQUE LIMITER, BUT DID NOT LOCK WHILE FINAL TIGHTENING. IT WAS REMOVED AND RE-INSERTED FROM ANOTHER ANGLE, BUT DID NOT LOCK. THE SURGEON FELT NO RESISTANCE DURING FINAL TIGHTENING. WHEN THE SURGEON INSERTED TI LOCKING SCREW (412.818S) FREEHAND INSTEAD, THE SCREW LOCKED AND PLATE FIXATION WAS COMPLETED. THERE WAS NO PATIENT HARM. THE SURGERY WAS A SURGICAL DELAY OF FIVE MINUTES REPORTED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368313 2.4MM TI VA-LCP 2-CLMN VLR DST PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1