BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 9615979 · Received January 22, 2020

    Report

    Report Number
    3004976965-2019-00049
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 17, 2019
    Report Date
    December 24, 2019
    Manufacturer
    VIANT MEDICAL, LLC
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RECEIVED AT VIANT FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE WELD ADJOINING THE RATCHET HOUSING AND THE OFFSET CUP IMPACTOR (OCI) WAS FRACTURED ALL AROUND AND THE RATCHET HOUSING WAS REMOVED FROM THE OCI BODY. THERE WERE SEVERAL DEFORMITIES ON THE RATCHET HOUSING, AS WELL AS IN THE SURROUNDING AREA OF THE RATCHET ASSEMBLY, WHICH ARE INCONSISTENT WITH INTENDED USE. THERE WERE SOME SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THERE WERE SOME GOUGES ON THE METAL HANDLE THAT ARE NOT CONSISTENT WITH INTENDED USE AS THE OCI IS INTENDED TO BE IMPACTED ONLY ON THE IMPACTION PLATE; THE OCI BODY, NEAR THE 2 LARGE PINS THAT ATTACH INTO THE OCI BODY, WAS DENTED ON ONE (1) SIDE, LIKELY FROM A LARGE IMPACTION IN THIS AREA, WHICH IS NOT INTENDED; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY DISCREPANCIES. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AND IS ATTRIBUTED TO UNINTENDED USE. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. REPORTED BY DISTRIBUTOR, DEPUY ORTHOPAEDICS, INC.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT UPON IMPACTION, THE SPRING LOADED RELEASE MECHANISM DISASSOCIATED FROM THE HANDLE RELEASING TENSION FROM THE DEVICE. NO ADVERSE EVENTS NOR PATIENT CONSEQUENCE WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81242 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC4194837

    Patients

    Seq Age Sex Outcome Treatment
    1