BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL HANDLE OFFSET CUP IMPACTOR

    MDR report key: 8756061 · Received July 2, 2019

    Report

    Report Number
    3004976965-2019-00018
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    May 21, 2019
    Report Date
    May 23, 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 RATCHET KEY COULD MOVE UP AND DOWN IN THE RATCHET HOUSING, HOWEVER IT DID NOT FUNCTION AS INTENDED. THERE WAS RESISTANCE WHEN ATTEMPTING TO RATCHET. UPON CLOSER EXAMINATION, THE WELD ADJOINING THE RATCHET HOUSING TO THE OFFSET CUP IMPACTOR (OCI) BODY IS FRACTURED. THE RATCHET HOUSING IS SLIGHTLY PROTRUDING UP FROM THE OCI BODY, WHICH IS NOT INTENDED, AND IS LIKELY THE CAUSE OF THE RESISTANCE FELT WHEN INSERTING THE RATCHET KEY INTO THE HOUSING. ADDITIONALLY, THERE IS DEFORMATION ON THE BACK SIDE OF THE RATCHET TRIGGER. THIS APPEARS TO HAVE BEEN CAUSED BY THE TRIGGER BEING PUSHED BACK AGAINST THE OCI BODY WITH GREAT FORCE, WHICH IS NOT INTENDED. THE RATCHET TEETH WERE SEVERELY WORN. THE AREA ON THE RATCHET KEY WHERE THE WEAR IS MOST PREVALENT IS TYPICALLY EXPOSED AND NOT LOCKED INTO THE RATCHET HOUSING WHEN THE OCI IS USED WITH A REMOVABLE NOSE AND AN IMPLANT PROPERLY ATTACHED. FOR THESE TEETH TO SEE THIS AMOUNT OF WEAR AND DEFORMATION, THE OCI WOULD EITHER HAVE TO BE SOMEHOW USED WITHOUT THE REMOVABLE NOSE, WHICH IS NOT INTENDED, OR BE USED WITH THE REMOVABLE NOSE AND BE TIGHTENED/RATCHETED DOWN TO AN EXTREME DEGREE, WHICH IS NOT INTENDED, AND WOULD LIKELY LEAD TO OTHER BREAKAGES AND DEFORMATIONS, POSSIBLY LEADING TO THE OBSERVED RATCHET HOUSING/OCI BODY WELD FRACTURE HOWEVER THAT IS UNKNOWN. IT IS UNKNOWN HOW THIS WEAR AND DEFORMATION CAME TO BE THIS HIGH UPON THE RATCHET KEY, NOR ON THE SECTION WHERE REMOVABLE NOSE IS INTENDED TO BE ASSEMBLED. THERE WERE ALSO SOME GOUGES OBSERVED ON THE ROUND TIP OF THE OCI WHERE THE REMOVABLE NOSE IS TYPICALLY ASSEMBLED, WHICH WERE NOT CONSISTENT WITH INTENDED USE. OTHER OBSERVATIONS: THERE WERE MANY SIGNS OF WEAR IN THE FORM OF SCRATCHES, NICKS AND GOUGES OBSERVED THROUGHOUT THE COMPLAINT SAMPLE; EACH OF THE SHORT PIN/FORK WELDS ON THE CARDAN JOINT NEAREST THE THREADED END WERE FRACTURED. EACH OF THE SHORT PIN/FORK WELDS ON THE CARDAN JOINT NEAREST THE BLUE KNOB END WERE ALSO SLIGHTLY FRACTURED; EACH OF THE LARGE PINS THAT LATCH INTO THE OCI BODY TO HOLD THE CHAIN ASSEMBLY IN PLACE WERE DEFORMED AND IT IS UNKNOWN WHAT CAUSED THE DEFORMATION; THE RETURNED COMPLAINT SAMPLE WAS ETCHED PER APPLICABLE DRAWINGS. THE APPLICABLE DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED. NO DISCREPANCIES WERE DISCOVERED. THIS COMPLAINT SAMPLE HAD EXPERIENCED APPROXIMATELY 4.56 YEARS OF USE. IT IS UNKNOWN AS TO HOW MANY SURGICAL PROCEDURES (CYCLES) THIS COMPLAINT SAMPLE HAD GONE THROUGH THROUGHOUT ITS LIFE IN THE FIELD. IN CONCLUSION, THE REPORTED EVENT IS CONFIRMED AS THE RATCHET MECHANISM DOES NOT FUNCTION AS INTENDED AND IS ATTRIBUTED TO WEAR AND UNINTENDED USE AS THERE WERE SIGNS OF EACH OBSERVED THROUGHOUT THE COMPLAINT SAMPLE. NO FURTHER INVESTIGATION IS REQUIRED WITH REGARD TO THIS COMPLAINT. EVENT NOTIFICATION WAS RECEIVED 23-MAY-2019 WHICH DID NOT MEET REPORTABILITY REQUIREMENTS AT THE TIME WITH THE INFORMATION AVAILABLE. HOWEVER, THE DEVICE WAS RECEIVED 4-JUN-2019 WHICH CONTAINED A FRACTURE AND HENCE MET THE REPORTING REQUIREMENTS. COMPLAINT INFORMATION RECEIVED FROM DISTRIBUTOR, DEPUY ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNKNOWN PATIENT PROCEDURE THAT THE SIDE OF THE IMPACTOR HANDLE DOESN'T MOVE UP OR DOWN. 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
    548331 METAL HANDLE OFFSET CUP IMPACTOR IMPACTOR HWA VIANT MEDICAL, LLC 255000115 PC2850961

    Patients

    Seq Age Sex Outcome Treatment
    1