BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE

    MDR report key: 3863039 · Received June 10, 2014

    Report

    Report Number
    1719045-2014-10248
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    (B)(4). NON-STERILE ARTICLE/PART WAS MANUFACTURED IN THE US UNDER ARTICLE 04.210.118 WITH LOT 7517722. MANUFACTURED IN MONUMENT ON NOVEMBER 20, 2013. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE WAS NOT IMPLANTED DUE TO COMPLAINED EVENT AND A SHORTER SCREW WAS USED IN ITS PLACE. IMPLANT DATE FIELD SHOULD HAVE BEEN LEFT BLANK ON INITIAL REPORT. 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 DEVICES WERE USED FOR A DISTAL RADIUS FRACTURE CASE. THE SCREW WAS INSERTED INTO THE ANGLED SCREW HOLE TOWARD THE RADIAL STYLOID PROCESS AT THE MOST DISTAL RADIAL SIDE USING THE TORQUE LIMITER. THE SURGEON FOUND THAT THE TORQUE LIMITER WAS SPINNING AND THE SCREW COULD NOT BE LOCKED. HE DIDN¿T HEAR A CLICKING SOUND OF THE TORQUE LIMITER, SO HE USED A SHORTER SCREW AS A SUBSTITUTE AND FINISHED THE OPERATION. DUE TO THE INCIDENT, THE OPERATION WAS EXTENDED FOR 15 MINUTES, THERE WAS NO PATIENT HARM. THIS REPORT IS 1 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337546 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES SELZACH 8750098

    Patients

    Seq Age Sex Outcome Treatment
    1