BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REAMER HANDLE

    MDR report key: 4102481 · Received August 27, 2014

    Report

    Report Number
    9614497-2014-00209
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    March 2, 2014
    Report Date
    May 14, 2016
    Manufacturer
    GREATBATCH MEDICAL SA
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: CORRECTED TO LXH.

    Additional Manufacturer Narrative · 1

    (B)(4) MEDICAL IS NOT THE LEGAL MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS REVIEWED AND THE REPORTED EVENT WAS CONFIRMED. THE POWER ADAPTER END TIP HAS FAILED. FAILURE MODE HAS EVIDENCE OF TORSIONAL OVERLOAD. THE SHOULDER NEXT TO THE POWER ADAPTER TIP IS SEVERELY WORN. 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 REQUIRED. (B)(4).

    Description of Event or Problem · 1

    PER EMAIL RECEIVED 05/07/2014 CUSTOMER REPORTS; DURING AN UNK PT PROCEDURE, THE HANDLE BROKE AT THE END WHERE THE DRILL IS ATTACHED. NO PT INJURY OR ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519030 ACETABULAR REAMER HANDLE REAMER HANDLE LXH GREATBATCH MEDICAL SA 2102-0410 V2010089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK