BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY SEPARATOR

    MDR report key: 10653514 · Received October 8, 2020

    Report

    Report Number
    1651501-2020-00017
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 9, 2021
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BODY SEPARATOR WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR): A REVIEW OF THE LOT RECORDS WAS CONDUCTED AND FOUND NO INDICATIONS OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. FAILURE ANALYSIS: VISUAL EXAMINATION OF THE PART FOUND THAT THE THREADED TIP OF THE BODY SEPARATOR WAS BROKEN OFF AND MISSING. THE FAILURE WAS CONFIRMED. ROOT CAUSE ANALYSIS: EXAMINATION OF THE PART CONFIRMED THAT THE MOST LIKELY CAUSE OF THE BREAK WAS THE PREVIOUSLY IDENTIFIED CAUSE OF APPLYING EXCESSIVE BENDING FORCE TO INSTRUMENT DURING USE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE LOT RECORDS WAS CONDUCTED AND FOUND NO INDICATIONS OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. THE COMPLAINT DESCRIPTION STATES THAT THE ¿DISTAL TIP OF INSERTER BROKE OFF INSIDE [THE] GLENOSPHERE DURING INSERTION¿. IT IS IMPORTANT TO NOTE THAT THE SEP-0920-068-001 BODY SEPARATOR IS NOT USED TO INSERT THE GLENOSPHERE BUT RATHER TO SEPARATE THE PROXIMAL HUMERAL BODY FROM THE DISTAL STEM IN CASES OF REVISION. AS THE PART HAS NOT YET BEEN RETURNED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. REVIEW OF PREVIOUS SIMILAR COMPLAINTS INDICATED THAT A POTENTIAL CAUSE WAS USER ERROR BY APPLYING EXCESSIVE BENDING FORCE TO INSTRUMENT. ADDITIONALLY, AS THE COMPLAINT DESCRIPTION CLAIMS THE INSTRUMENT FAILED WHILE PERFORMING ACTIVITIES IT WAS NOT INTENDED FOR, ANOTHER POTENTIAL CAUSE IS USER ERROR BY USING THE INSTRUMENT FOR THE WRONG APPLICATION. IF THE PART IS LATER RETURNED, THIS COMPLAINT MAY BE REOPENED AND FURTHER INVESTIGATION CONDUCTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE DISTAL TIP OF INSERTER BROKE OFF INSIDE GLENOSPHERE DURING INSERTION WHILE PERFORMING A REVERSE SHOULDER ARTHROPLASTY PROCEDURE. THE BROKEN TIP WAS LEFT IN SITU AS REMOVAL WOULD HAVE CAUSED POTENTIAL INJURY. THE SURGEON WORKED 30 MINUTES TRYING TO REMOVE THE TIP OF THE INSTRUMENT FROM THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118190 BODY SEPARATOR TITAN TOTAL SHOULDER INSTRUMENTS HXW ASCENSION ORTHOPEDICS 204609-3

    Patients

    Seq Age Sex Outcome Treatment
    1