BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN STRAIGHT CUP IMPACTOR

    MDR report key: 4083416 · Received September 12, 2014

    Report

    Report Number
    1818910-2014-27884
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMS THE REPORTED EVENT OF HANDLE BREAKAGE. PREVIOUS INVESTIGATIONS FOUND DESIGN IS ATTRIBUTED TO THE HANDLES CRACKING; ECO 256356 WAS IMPLEMENTED ON (B)(4) 2008 TO CHANGE THE MATERIAL FROM RADEL TO ALUMINUM. THE RETURNED DEVICE MADE PRIOR TO THESE CHANGES. THE ROOT CAUSE IS ATTRIBUTED TO PRODUCT DESIGN. FURTHER CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    THE IMPACTOR BROKE DURING IMPACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564887 PINN STRAIGHT CUP IMPACTOR HIP INSTRUMENT/TRIAL LXH 1818910 DEPUY ORTHOPAEDICS, INC. J0204

    Patients

    Seq Age Sex Outcome Treatment
    1