BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 9497177 · Received December 19, 2019

    Report

    Report Number
    3004976965-2019-00043
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    October 9, 2019
    Report Date
    October 15, 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 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. ADDITIONALLY, THE RATCHET HOUSING HAD BEEN ROTATED APPROXIMATELY ONE-HUNDRED EIGHTY (180) DEGREES AND THE RATCHET COULD NO LONGER BE INSTALLED AS INTENDED. THE RATCHET HOUSING WAS REMOVED AND IT WAS OBSERVED THAT THE TEETH ON THE RATCHET TRIGGER THAT CONNECT WITH THE RATCHET KEY TEETH WERE WORN/DEFORMED, INDICATING UNINTENDED USE. THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THERE WAS A SMALL FRACTURE OBSERVED IN THE WELD ADJOINING THE METAL HANDLE AND THE OCI BODY; THERE WERE GOUGES INCONSISTENT WITH INTENDED USE OBSERVED THROUGHOUT THE OCI BODY, PARTICULARLY NEAR THE REMOVABLE NOSE AND ON THE UNDERSIDE OF THE OCI BODY BETWEEN THE RATCHET AND WHERE THE METAL HANDLE/OCI BODY ARE WELDED TOGETHER; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. REVIEW OF PRODUCTION RECORDS DID NOT REVEAL ANY DISCREPANCIES. THE EVENT IS ATTRIBUTED TO UNINTENDED USE. NO FURTHER INVESTIGATION IS REQUIRED. EVENT NOTIFICATION WAS RECEIVED 15-OCT-2019 WHICH DID NOT MEET REPORTABILITY REQUIREMENTS AT THE TIME WITH THE INFORMATION AVAILABLE. HOWEVER, THE DEVICE WAS RECEIVED 20-NOV-2019 WHICH CONTAINED A FRACTURE AND MET THE VIANT REPORTING REQUIREMENTS. REPORTED BY DISTRIBUTOR, DEPUY ORTHOPAEDICS, INC, FOREIGN AS THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE SPRING IS DEFECTIVE WHEN LOCKING THE CUP. 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
    1291726 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC4316499

    Patients

    Seq Age Sex Outcome Treatment
    1