BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM TRIAL, 12MM

    MDR report key: 6725661 · Received July 19, 2017

    Report

    Report Number
    1651501-2017-00030
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Report Date
    June 10, 2017
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON SEPTEMBER 7, 2017 RESULTS: THE INSTRUMENT WAS NOT RETURNED; THEREFORE, A FAILURE ANALYSIS COULD NOT BE CONDUCTED. DHR REVIEW; THE MANUFACTURING RECORDS FOR PRODUCT ID TRL-0920-025-12 COULD NOT BE REVIEW DUE TO THE LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS DURING THE LAST 5 YEARS FOUND 13 HUMERAL STEM TRIAL COMPLAINTS REPORTED FOR BREAKAGE. DURING THAT PERIOD OF TIME, THERE HAVE BEEN APPROXIMATELY 3407 TSS SURGERIES REPORTED. THIS REPRESENTS A COMPLAINT RATE OF 0.38% (13/3407). 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. BASED UPON PREVIOUS INCIDENTS, THE CAUSE OF THE DEVICE BREAKAGE MAY HAVE RESULTED FROM THE USER¿S TECHNIQUE, SUCH AS MALLET SELECTION USED FOR IMPACTION OR MATERIAL/HEAT TREATMENT COMBINATION RESULTING IN A FAILURE AFTER REPEATED IMPACTS. PATIENT PHYSIOLOGY, SUCH AS DENSE OR HARD BONE MAY ALSO HAVE CONTRIBUTED TO THE BREAKAGE IN THE DEVICE. BREAKAGE MAY HAVE OCCURRED DUE TO OVER USE OF THE DEVICE. IN THIS CASE IT WAS REPORTED THE TRIAL STEM WAS NOT FULLY IMPACTED AT THE POINT OF FAILURE, AND THE THREADS WERE BROKEN ABOVE THE OSTEOTOMY LINE.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ONE (1) OF 2 REPORTS - OTHER MFG REPORT NUMBER - 1651501-2017-00031. IT WAS REPORTED THAT DURING THE PREPARATION OF THE HUMERAL CANAL FOR A REVERSE SHOULDER ARTHROPLASTY, THE HUMERAL STEM TRIAL BROKE OFF THE STEM TRIAL HANDLE. THE TRIAL STEM WAS NOT FULLY IMPACTED AT THE POINT OF FAILURE, AND THE THREADS WERE BROKEN ABOVE THE OSTEOTOMY LINE. THE DOCTOR WAS ABLE TO RETRIEVE THE STEM TRIAL WITH THE USE OF A VICE GRIP 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
    505000 HUMERAL STEM TRIAL, 12MM TITAN TOTAL SHOULDER INSTRUMENTS LXH ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1