BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM TRIAL, 14MM

    MDR report key: 6988984 · Received October 30, 2017

    Report

    Report Number
    1651501-2017-00042
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    September 26, 2017
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    HTW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON NOVEMBER 9, 2017. RESULTS: DHR REVIEW; THE MANUFACTURING RECORDS FOR PRODUCT ID TRL-0920-025-14 COULD NOT BE REVIEWED DUE TO THE LOT NUMBER NOT PROVIDED BY THE COMPLAINANT FOR THE REPORTED INCIDENT ALLEGED. COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS DURING THE LAST 5 YEARS FOUND 16 HUMERAL STEM TRIAL COMPLAINTS REPORTED FOR BREAKAGE. DURING THAT PERIOD OF TIME, THERE HAVE BEEN APPROXIMATELY 3529 TSS SURGERIES REPORTED. THIS REPRESENTS A COMPLAINT RATE OF 0.45% (16/3529) AS SOME OF THE REPORTED EVENTS WERE ASSOCIATED WITH A SERIOUS SEVERITY LEVEL, THIS INDICATES AN ADVERSE TREND. CONCLUSION: AT THIS TIME, THE ROOT CAUSES FOR THIS INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION OF THE HUMERAL CANAL FOR A TOTAL SHOULDER ARTHROPLASTY, THE HUMERAL STEM TRIAL BROKE OFF OF THE STEM TRIAL HANDLE AND WAS LODGED IN THE PATIENT¿S HUMERAL CANAL. AFTER DRILLING INTO THE BROKEN STEM TRIAL, THE SURGEON WAS ABLE TO REMOVE THE INSTRUMENT. NO PATIENT INJURY REPORTED AND THE EVENT LEAD TO 40 MINUTES SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766339 HUMERAL STEM TRIAL, 14MM TITAN TOTAL SHOULDER INSTRUMENTS HTW ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1