BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 9030134 · Received September 13, 2019

    Report

    Report Number
    3004976965-2019-00028
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    August 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 INCOMPLETE AT VIANT FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE CHAIN ASSEMBLY SHAFT WAS FRACTURED BETWEEN THE LARGE PIN COMPONENT THAT LOCKS THE CHAIN ASSEMBLY INTO THE OCI BODY AND THE BLUE KNOB. WHEN ASSEMBLING THE CHAIN ASSEMBLY, THE CARDAN ASSEMBLY IS ATTACHED TO THE SHAFT COMPONENT, THEN A CARDAN RING (NOT RECEIVED WITH SAMPLE), THE LARGE PIN COMPONENT AND A STOP CLIP COMPONENT, WHICH IS PINNED AND WELDED IN PLACE. THE SHAFT BROKE UNDER THIS STOP CLIP COMPONENT RIGHT WHERE IT IS PINNED INTO THE SHAFT. OTHER OBSERVATIONS: THE BLUE KNOB ON THE CHAIN ASSEMBLY CONTAINED DEFORMITIES INCONSISTENT WITH INTENDED USE; EACH OF THE SHORT PIN/FORK WELDS WERE OBSERVED TO BE FRACTURED AND THERE WAS ADHESIVE RESIDUE ALL OVER EACH OF THE CARDAN JOINTS; ONE (1) OF THE TWO (2) LARGE PINS THAT LOCK INTO THE OCI BODY IS SEVERELY DEFORMED, INCONSISTENT WITH INTENDED USE. THERE WERE DEFORMITIES ON THE COMPONENT CONTAINING THESE PINS AS WELL. THE OCI BODY UNDERNEATH THE LARGE PIN COMPONENT IS DEFORMED AND ALSO SLIGHTLY FRACTURED AT THE TWO (2) AFOREMENTIONED LATCH PLATE PINS. THE RATCHET TEETH SHOWED SOME SIGNS OF WEAR/DEFORMATION, SOME INCONSISTENT WITH INTENDED USE; THE RATCHET HOUSING CONTAINED DEFORMITIES INCONSISTENT WITH INTENDED USE AND THERE WERE BLUISH STAINS OF UNKNOWN ORIGIN ON THE RATCHET HOUSING AND OCI BODY IN THAT AREA; THE WELD ADJOINING THE METAL HANDLE AND OCI BODY IS PARTIALLY FRACTURED, DUE TO UNINTENDED USE AS THERE ARE SEVERAL IMPACTIONS ON AND AROUND THE SPECIFIC AREA WHERE IT IS FRACTURED. THE IMPACTOR IS ONLY INTENDED TO BE IMPACTED ON THE IMPACTION PLATE. THERE WERE SEVERAL IMPACTIONS OBSERVED ON THE IMPACTION PLATE, AS INTENDED, HOWEVER THERE WERE A FEW LARGE GOUGES AROUND THE OUTER DIAMETER OF THE IMPACTION PLATE THAT MAY HAVE BEEN OFF-AXIS, WHICH IS NOT INTENDED; THERE WAS DEFORMATION IN THE FORM NICKS AND GOUGES OBSERVED THROUGHOUT THE OCI BODY THAT WERE NOT CONSISTENT WITH INTENDED USE. THERE WAS ALSO AN ADHESIVE SUBSTANCE, LIKELY THE SAME AS OBSERVED ON THE CARDAN JOINTS, THAT WAS ON THREE (3) DISTINCT PARTS OF THE OCI BODY: BETWEEN THE RATCHET AND LATCH ASSEMBLIES AND WHERE EACH CARDAN JOINT RESIDES. THE OCI IS NOT INTENDED TO BE USED WITH TAPE OR ADHESIVE AS OBSERVED. THERE WERE SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE AND IT WAS ETCHED PER APPLICABLE DRAWINGS. NO DISCREPANCIES WERE DISCOVERED DURING REVIEW OF PRODUCTION RECORDS. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AND ATTRIBUTED TO MISUSE AS THERE WERE MANY SIGNS OF UNINTENDED USE OBSERVED THROUGHOUT THE COMPLAINT SAMPLE, SOME OF WHICH CONTRIBUTED TO THE SHAFT FRACTURE. NO FURTHER INVESTIGATION WITH REGARD TO THIS COMPLAINT IS REQUIRED. EVENT DATE UNKNOWN. COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE IMPACTOR BROKE AT THE ROTATING ARM WHILE THE SURGEON WAS IMPACTING. 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
    812859 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC3664265

    Patients

    Seq Age Sex Outcome Treatment
    1