BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL BODY INSERTER/ EXTRACTOR KNOB

    MDR report key: 6694262 · Received July 7, 2017

    Report

    Report Number
    1651501-2017-00027
    Event Type
    Malfunction
    Date Received
    July 7, 2017
    Date of Event
    May 5, 2017
    Report Date
    June 13, 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 JUNE 20, 2017. RESULTS: THE HUMERAL BODY INSERTER/EXTRACTOR KNOB WAS NOT RETURNED TO AUSTIN. THE NATURE OF THE DEVICE FAILURE WAS NOT CLARIFIED BY THE COMPLAINANT WITH ONLY ¿HAD ISSUE¿ WITH DEVICE AS THE ONLY DESCRIPTION OF THE COMPLAINT. ACCORDING TO THE HISTORICAL COMPLAINT DESCRIPTION, THE DEVICE FRACTURED AT THE THREADED PORTION DURING IMPACTING. NO FURTHER INFORMATION PROVIDED DHR REVIEW; NO PROCESS DEVIATION, ANOMALIES, OR ANY NONCONFORMANCE WERE IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS DURING THE LAST 5 YEARS FOUND 4 HUMERAL BODY INSERTER/ EXTRACTOR KNOB COMPLAINT RECORDS. DURING THAT PERIOD OF TIME, THERE HAVE BEEN APPROXIMATELY (B)(4) RSS SURGERIES REPORTED. THIS REPRESENTS A COMPLAINT RATE OF (B)(4) AS THIS EVENT WAS IN CONTACT WITH THE PATIENT AND LED TO A SIGNIFICANT SURGICAL DELAY, THE SURGICAL IMPACT OF THE EVENT IS A MODERATE SEVERITY LEVEL, BUT DOES NOT INDICATE AN ADVERSE TREND. CONCLUSION: THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION PROVIDED. MANUFACTURING RECORDS SHOWED NO EVIDENCE OF ANOMALIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POTENTIAL CAUSE FOR BREAKAGE OF THE INS-0960-094-01 HUMERAL BODY INSERTER/ EXTRACTOR KNOB MAY BE DUE TO THE KNOW EITHER NOT BEING TIGHTENED SUFFICIENTLY, OR LOOSENING FROM THE VIBRATION OF STRIKING THE INSTRUMENT RESULTING IN BREAKAGE.

    Description of Event or Problem · 1

    ONE OF 2 REPORTS. OTHER MFG REPORT NUMBER: 1651501-2017-00028. IT WAS REPORTED AN UNSPECIFIED FAILURE OF THE UNIT. NO PATIENT INJURY REPORTED; HOWEVER, THE EVENT LEAD TO 1 HOUR SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473497 HUMERAL BODY INSERTER/ EXTRACTOR KNOB ORTHOPEDIC SHOULDER LXH ASCENSION ORTHOPEDICS 203444-01

    Patients

    Seq Age Sex Outcome Treatment
    1