BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24MM COCR RADIAL HEAD

    MDR report key: 3677715 · Received March 13, 2014

    Report

    Report Number
    1719045-2014-10053
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 19, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KWI
    PMA / PMN Number
    PK112030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. ADDITIONAL INFORMATION PROVIDED. NEMCOMED (PRESENTLY AVALIGN TECHNOLOGIES ¿ NEMCOMED) MANUFACTURED THE 24MM COCR RADIAL HEAD STANDARD HEIGHT, P/N 04.402.024S, LOT NUMBER 6955108, (B)(4). THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. 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

    DURING RADIAL HEAD PROSTHESIS THE SET SCREW BROKE OFF WHILE THE SURGEON WAS ATTACHING THE RADIAL HEAD TO THE RADIAL STEM. THE SCREWDRIVER IS SUPPOSED TO HAVE A TORQUE LIMITER ATTACHED WHILE INSERTING THE SET SCREW. THE LIMITING DEVICE WAS NOT ATTACHED. THE SCREW HEAD SNAPPED AT THE HEAD AND WAS REMOVED FROM THE SCREWDRIVER TIP, AND IS NOW AVAILABLE FOR EVALUATION. THE SURGEON CONTINUED WITH THE PROCEDURE WITH ONLY THE SCREW SHAFT SECURING THE HEAD AND STEM. THE PROCEDURE WAS COMPLETED TO THE SATISFACTION OF THE SURGEON. THE SCREW SHAFT REMAINS EMBEDDED IN THE RADIAL HEAD, PART NUMBER 09.402.024S, JOINING THE RADIAL HEAD AND RADIAL STEM. THE SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY WITHOUT DELAY AND WITHOUT ANY ADVERSE EVENT TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150640 24MM COCR RADIAL HEAD PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER KWI SYNTHES MONUMENT 6955108

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR