BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 9406234 · Received December 3, 2019

    Report

    Report Number
    3004976965-2019-00039
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    October 15, 2019
    Report Date
    October 21, 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 RATCHET WOULD COME LOOSE WHEN IMPACTED ON THE IMPACTION PLATE AS INTENDED. THE WELD ADJOINING THE OFFSET CUP IMPACTOR (OCI) BODY AND RATCHET HOUSING WAS FRACTURED ALL AROUND AND THERE WERE SEVERAL DEFORMITIES OBSERVED ON THE RATCHET HOUSING, AS WELL AS IN THE SURROUNDING AREA OF THE RATCHET ASSEMBLY, WHICH ARE INCONSISTENT WITH INTENDED USE. THERE WERE MANY SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THERE WERE GOUGES INCONSISTENT WITH INTENDED USE OBSERVED THROUGHOUT THE OCI BODY, PARTICULARLY NEAR THE REMOVABLE NOSE, MINIMALLY ON THE BLUE KNOB AND ON THE METAL HANDLE; THE FORK/PIN WELDS ON THE FORK NEAREST THE BLUE KNOB OF THE CARDAN JOINT NEAREST THE BLUE KNOB WERE FRACTURED BUT THE JOINT APPEARED FUNCTIONAL; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY DISCREPANCIES. THE EVENT IS ATTRIBUTED TO WEAR AND UNINTENDED USE. NO FURTHER INVESTIGATION IS REQUIRED. EVENT NOTIFICATION WAS RECEIVED 21-OCT-2019 WHICH DID NOT MEET REPORTABILITY REQUIREMENTS AT THE TIME WITH THE INFORMATION AVAILABLE. HOWEVER, THE DEVICE WAS RECEIVED 4-NOV-2019 WHICH CONTAINED A FRACTURE AND MET THE VIANT REPORTING REQUIREMENTS. REPORTED BY DISTRIBUTOR, DEPUY ORTHOPAEDICS, INC.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON A FEMALE PATIENT THAT IMPLANTING THE CUP THE GREAT BATCH HANDLE WAS DEFECTIVE. THE LOCKING MECHANISM WAS POPPING UP WHEN IMPACTING THE CUP. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY REPORTED. 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
    1199449 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC2883752

    Patients

    Seq Age Sex Outcome Treatment
    1