BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 8970794 · Received September 6, 2019

    Report

    Report Number
    3004976965-2019-00027
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 9, 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 INCOMPLETE (NO REMOVABLE NOSE) 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 THE HOUSING HAD COMPLETELY DISASSEMBLED FROM THE OCI BODY. 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. THE RATCHET TEETH SHOWED SOME SIGNS OF WEAR/DEFORMATION, SOME INCONSISTENT WITH INTENDED USE AS WELL. OTHER OBSERVATIONS: THE OCI BODY WAS DISCOLORED BETWEEN THE RATCHET HOUSING AREA AND THE CHAIN ASSEMBLY LOCKING AREA; THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THERE WERE SEVERAL SCRATCHES AND GOUGES BETWEEN THE NOSE OF THE OCI AND THE CHAIN ASSEMBLY LOCKING AREA, CONSISTENT WITH IMPACTION. THERE WERE ALSO SEVERAL SCRATCHES AND GOUGES CONSISTENT WITH IMPACTION NEAR THE RATCHET AREA, WHERE THE OCI BODY AND METAL HANDLE ARE WELDED TOGETHER. EACH OF THESE OBSERVATIONS OF POTENTIAL IMPACTION ARE INCONSISTENT WITH INTENDED USE; THE OCI BODY HAS SLIGHTLY CRACKED WHERE EACH OF THE LATCH PLATE PINS PROTRUDE UP THROUGH THE OCI BODY; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE WELD ADJOINING THE RATCHET HOUSING AND OCI BODY IS FRACTURED ALL AROUND AND THE RATCHET HOUSING DISASSEMBLED FROM THE OCI BODY. THERE WERE SEVERAL OBSERVATIONS OF DEFORMATION THAT WERE NOT CONSISTENT WITH INTENDED USE, WHICH CONTRIBUTED TO THE OBSERVED FRACTURE AND DISASSEMBLY OF THE RATCHET HOUSING. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. REPORT SOURCE: COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR, DEPUY ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ORTHOPEDIC PROCEDURE THAT THE CUP IMPACTOR HANDLE IS BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO ADVERSE EVENTS NOR PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764068 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC3263958

    Patients

    Seq Age Sex Outcome Treatment
    1