BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEWIN BONE CLAMP SERR 180MM

    MDR report key: 5591288 · Received April 20, 2016

    Report

    Report Number
    2916714-2016-00308
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Date of Event
    January 26, 2016
    Report Date
    December 5, 2017
    Manufacturer
    CONTRACT MANUFACTURER: AUGUST REUCHLEN GMBH
    Product Code
    HXD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS AT HAND. NO PRODUCT IS AVAILABLE AND THEREFORE AN ANALYSIS IS NOT POSSIBLE. NO CAPA IS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PT WAS UNDERGOING A RIGHT TOTAL HIP ARTHROPLASTY, DURING THE PROCEDURE, THE SURGEON WAS USING THE MD455 (CLAMP) WHEN THE TIP OF ONE OF THE PRONGS BROKE OFF. THE SURGICAL TEAM WAS ABLE TO RETRIEVE THE BROKEN TIP. NO HARM TO PT AND NO RETAINED FOREIGN OBJECT. DIAGNOSIS OR REASON FOR USE: USED DURING TOTAL HIP ARTHROPLASTY, EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. COMPLAINT RECEIVED BY MEDWATCH REPORT #MW5060204. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245434 LEWIN BONE CLAMP SERR 180MM CLAMP HXD CONTRACT MANUFACTURER: AUGUST REUCHLEN GMBH MD455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other