BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/2H SHAFT/RT-STER

    MDR report key: 3932769 · Received July 14, 2014

    Report

    Report Number
    1000562954-2014-10121
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    PMA / PMN Number
    PK083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE PLATE SHOWED VISIBLE SIGNS OF USAGE (SCRATCHES) BUT IS IN WORKING CONDITION AS ALL THREADS EXAMINED SHOWED NO VISIBLE DAMAGE. THE MANUFACTURING DOCUMENTATION WAS REVIEWED AND NO DISCREPANCIES WERE OBSERVED AND THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ADDITIONALLY A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND THERE WERE NO OTHER SIMILAR COMPLAINTS FOR THE PART. IT IS LIKELY THAT THERE MAY HAVE BEEN MISALIGNMENT OF THE SCREW IN THE LOCKING HOLE OR THE DRILLED HOLE DIAMETER WAS TOO LARGE FOR THE SCREW. HOWEVER, NO PRODUCT FAULT COULD BE FOUND. DEVICE WAS NOT IMPLANTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PRODUCTS WERE USED FOR A RIGHT SIDE DISTAL RADIUS FRACTURE. UPON FIXING THE VARIABLE ANGLE (VA) DISTAL RADIUS PLATE; THE SURGEON USED A VA DRILL SLEEVE FOR THE HOLE NEAREST TO THE ELBOW AND WITH A SCREW DRIVER INSERTED THE VA LOCKING SCREW. THE SURGEON DID NOT FEEL THAT THE SCREW HAD LOCKED. THEREFORE, HE TRIED TO REMOVE THE SCREW AND RE-INSERT IT. THE SCREW RAN IDLE AND THE SURGEON WAS NOT ABLE TO REMOVE IT. THE SURGEON THEN HAD TO REMOVE ALL SCREWS AND THE PLATE. THE OPERATION WAS COMPLETED BY USING ANOTHER SET OF PLATE AND SCREWS AND THERE WAS NO REPORT OF PATIENT RESIDUE. THERE WAS A SURGICAL DELAY OF THIRTY MINUTES REPORTED. THIS REPORT IS FOR 1 OF 2 COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409864 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PL 6H HD/2H SHAFT/RT-STER PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8894762

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR