BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 8828992 · Received July 25, 2019

    Report

    Report Number
    3004976965-2019-00024
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 1, 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 OFFSET CUP IMPACTOR (OCI) BODY WAS FRACTURED ALL AROUND. THERE WERE SOME DEFORMITIES ON THE RATCHET HOUSING AND TRIGGER PLATE THAT ARE NOT CONSISTENT WITH INTENDED USE AND MAY HAVE CONTRIBUTED TO THE FRACTURE. THE RATCHET TEETH WERE SEVERELY WORN. OTHER OBSERVATIONS: THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THE WELD ADJOINING THE OCI BODY AND THE METAL HANDLE WAS FRACTURED ALL AROUND. ALSO, THE OCI BODY HAD HAIRLINE FRACTURES ON EACH SIDE, WHERE THE TWO (2) LONG LATCH PLATE PINS COME UP TO HOLD THE LARGE CHAIN ASSEMBLY PINS IN PLACE. THE LARGE PINS ON THE CHAIN ASSEMBLY, WHICH LATCH ONTO THE BODY WITH THE LONG LATCH PINS, WERE ALSO DEFORMED AND THERE WAS DEFORMATION ON THE OCI BODY BELOW WHERE THESE LOCK INTO THE OCI BODY. THERE WERE MANY GOUGES ON THE METAL HANDLE, WHICH ARE NOT CONSISTENT WITH INTENDED USE AND LIKELY CONTRIBUTED TO THE AFOREMENTIONED FRACTURES; THERE WAS ADHESIVE ON THE BODY OF THE OCI WHICH IS NOT INTENDED; THE SHORT PIN/FORK WELD ON THE CARDAN JOINT NEAREST THE THREADS WERE FRACTURED AND THE CARDAN JOINT APPEARED TO BE ASSEMBLED CORRECTLY; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. A REVIEW OF THE APPLICABLE PRODUCTION RECORDS DID NOT REVEAL ANY DISCREPANCIES. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE RATCHET HOUSING/OCI BODY WELD IS FRACTURED ALL AROUND AND THE RATCHET TEETH ARE WORN. ADDITIONALLY, THE OCI BODY IS SLIGHTLY FRACTURED AND THE WELD ADJOINING THE OCI BODY AND METAL HANDLE IS FRACTURED ALL AROUND. THERE WERE MANY SIGNS OF UNINTENDED USE OBSERVED THROUGHOUT THE COMPLAINT SAMPLE THAT CONTRIBUTED TO THE FRACTURES. ADDITIONALLY, THE COMPLAINT SAMPLE WAS WORN. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. VIANT WILL CONTINUE TO MONITOR FOR TRENDS. REPORT SOURCE: COMPLAINT INFORMATION PROVIDED BY DISTRIBUTOR, DEPUY ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THE TENSIONING DEVICE STRIPPED ON THE CUP INSERTER. 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
    622928 METAL HANDLE OFFSET CUP IMPACTOR CUP IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC2883757

    Patients

    Seq Age Sex Outcome Treatment
    1