BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 8970795 · Received September 6, 2019

    Report

    Report Number
    3004976965-2019-00026
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 7, 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 WAS PROTRUDING OUT OF THE OCI BODY. THE HOUSING COULD BE 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. ONE (1) OF THE TWO (2) LARGE PINS ON THE CHAIN ASSEMBLY IS SEVERELY DEFORMED, AND THE OCI BODY AREA UNDER THE COMPONENT CONTAINING THESE PINS IS ALSO DEFORMED, EACH INCONSISTENT WITH INTENDED USE. THERE WERE DEFORMITIES ON THE COMPONENT CONTAINING THESE PINS AS WELL. THE OCI BODY IS ALSO SLIGHTLY FRACTURED AT THE TWO (2) LATCH PLATE PINS. OTHER OBSERVATIONS: THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; THERE WAS AN ADHESIVE SUBSTANCE OBSERVED ON PARTS OF THE OCI BODY, AS WELL AS PARTS OF THE CHAIN ASSEMBLY, WHICH IS NOT CONSISTENT WITH INTENDED USE; ON THE CARDAN JOINT NEAREST THE BLUE KNOB, THE FORK NEAREST THE BLUE KNOB WAS BENT OUTWARD SLIGHTLY AND ACCORDING TO THE BLOCK, THE JOINT MAY BE ASSEMBLED INCORRECTLY. THE OBSERVED BENT FORK WAS NOT IMPEDING THE ROTATION OF THE CHAIN ASSEMBLY; THE BLUE KNOB ON THE CHAIN ASSEMBLY HAD DEFORMITIES PRESENT THAT ARE NOT CONSISTENT WITH INTENDED USE; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. PRODUCTION RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES. 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 COULD BE DISASSEMBLED FROM THE OCI BODY. THERE WERE SEVERAL OBSERVATIONS OF DEFORMATION THAT WERE NOT CONSISTENT WITH INTENDED USE, WHICH CONTRIBUTED TO THE OBSERVED FRACTURE. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. REPORT SOURCE: COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR, DEPUY ORTHOPAEDICS. REPORTED EVENT INITIALLY DID NOT MEET REPORTABILITY REQUIREMENTS, HOWEVER UPON RECEIPT OF THE DEVICE 04-SEP-2019, THE EVENT BECAME REPORTABLE UPON OBSERVATION OF THE FRACTURED RATCHET HOUSING/OCI BODY WELD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE CUP INSERTER HANDLE WAS DEFECTIVE. THE LOCKING LATCH WOULD NOT ENGAGE CAUSING THE CUP TO ROTATE. NO PIECES WERE REPORTEDLY BROKEN OFF AND NO ADVERSE EVENTS NOR PATIENT CONSEQUENCE WERE REPORTED AS A RESULT OF THE MALFUNCTION. HOWEVER, UPON RECEIPT, THE RATCHET HOUSING WAS OBSERVED TO BE FRACTURED AWAY FROM THE IMPACTOR BODY BUT STILL CONTAINED IN THE IMPACTOR BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764065 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC3206031

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR