BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER SHAFT

    MDR report key: 4102507 · Received August 27, 2014

    Report

    Report Number
    9614497-2014-00206
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    GREATBATCH SA
    Product Code
    EJB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED FAILURE WAS CONFIRMED. THE MARRED SURFACES NEAR THE FRACTURE SURFACE INDICATED MISUSE. THE LOCKING COLLAR RETAINING PIN WELDS ARE CRACKED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. MANUAL SURGICAL INSTRUMENTS HAVE A LIMITED LIFE-SPAN WHICH IS GENERALLY DETERMINED BY WEAR OR DAMAGE DUE TO REPEATED INTENDED USE. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    PER EMAIL RECEIVED ON 04/16/2014 CUSTOMER REPORTS; DURING AN UNK PT PROCEDURE, THE TIP OF THE REAMER HANDLE BROKE OFF DUE TO THE TORQUE NEEDED TO REAM THE ACETABULUM. NO PT INJURY OR ADVERSE EVENTS REPORTED. SURGICAL DELAY WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519095 ACETABULAR REAMER SHAFT REAMER HANDLE EJB GREATBATCH SA 1206-90-10 56505946

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK