BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 7546526 · Received May 25, 2018

    Report

    Report Number
    3004976965-2018-00034
    Event Type
    Malfunction
    Date Received
    May 25, 2018
    Date of Event
    April 25, 2018
    Report Date
    April 27, 2018
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RECEIVED AT INTEGER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE OFFSET CUP IMPACTOR (OCI) WAS RECEIVED FRACTURED AND DISASSEMBLED. THE WELD ADJOINING THE OCI BODY AND METAL HANDLE WAS FRACTURED ALL AROUND. THIS ALLOWED THE HANDLE TO BE UNSCREWED FROM THE OCI BODY, WHICH IS HOW THE COMPLAINT SAMPLE WAS RECEIVED. THERE WERE SOME IMPACTIONS OBSERVED IN THE SURROUNDING AREA OF THE WELD FRACTURE. THESE ARE OFF-AXIS IMPACTIONS AND MAY HAVE CONTRIBUTED TO THE FRACTURE OVER TIME. OTHER OBSERVATIONS: THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES THROUGHOUT THE COMPLAINT SAMPLE; THE IMPACTION PLACE SHOWED MANY IMPACTIONS CONSISTENT WITH INTENDED USE; THE RATCHET HOUSING WELD WAS CRACKED NEARLY ALL AROUND. THE FUNCTION OF THE RATCHET MECHANISM COULD NOT BE TESTED AS THE IMPACTION PLATE WAS REMOVED FROM THE OCI. IMPACTION COULD NOT BE SIMULATED; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. A MANUFACTURING REVIEW DID NOT REVEAL ANY DISCREPANCIES. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE WELD ADJOINING THE OCI BODY AND METAL HANDLE WAS FRACTURED ALL AROUND AND THE METAL HANDLE WAS UNSCREWED FROM THE OCI BODY. THE COMPLAINT SAMPLE WAS WORN AND OFF-AXIS IMPACTIONS WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE FRACTURE OVER TIME. NO FURTHER INVESTIGATION IS REQUIRED. COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, DEPUY ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A PATIENT THAT THE IMPACTOR HANDLE IS LOOSE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387234 METAL HANDLE OFFSET CUP IMPACTOR CUP IMPACTOR HWA GREATBATCH MEDICAL 255000115 PC2883783

    Patients

    Seq Age Sex Outcome Treatment
    1