BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL BODY INSERTER/ EXTRACTOR KNOB

    MDR report key: 6676468 · Received June 29, 2017

    Report

    Report Number
    1651501-2017-00024
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    April 7, 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 BROKEN HUMERAL BODY INSERTER/EXTRACTOR KNOB WAS NOT RETURNED. DHR REVIEW; LOT NUMBER PM0281 DID NOT MATCH ANY EXISTING MANUFACTURING RECORDS CURRENTLY ON RECORD. THEREFORE, THE MANUFACTURING RECORD COULD NOT BE LOCATED AND REVIEWED FOR THIS COMPLAINT AT THIS TIME. IF ANY ADDITIONAL INFORMATION REGARDING THE LOT NUMBER IS RECEIVED, THE MANUFACTURING RECORD WILL BE REVIEWED AT A LATER DATE. COMPLAINTS HISTORY; A REVIEW OF COMPLAINT RECORDS IN TRACKWISE DURING THE LAST 5 YEARS FOUND 4 HUMERAL BODY INSERTER/ EXTRACTOR KNOB COMPLAINT RECORDS. DURING THAT PERIOD OF TIME, THERE HAVE BEEN APPROXIMATELY 2587 RSS SURGERIES REPORTED. THIS REPRESENTS A COMPLAINT RATE OF (B)(4). CONCLUSION: THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION PROVIDED. MANUFACTURING RECORDS SHOW 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 KNOB EITHER NOT BEING TIGHTENED SUFFICIENTLY, OR LOOSENING FROM THE VIBRATION OF STRIKING THE INSTRUMENT RESULTING IN BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE DURING IMPLANTATION OF THE FINAL STEM WITH THE REVERSE BODY INSIDE HUMERUS. IT WAS NOT POSSIBLE TO REMOVE THE THREADED PART JOINING THE FINAL PARTS. NO PATIENT INJURY REPORTED AND THE EVENT LEAD TO 1 HOUR 30 MINUTES SURGICAL DELAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459002 HUMERAL BODY INSERTER/ EXTRACTOR KNOB ORTHOPEDIC SHOULDER LXH ASCENSION ORTHOPEDICS PM0281

    Patients

    Seq Age Sex Outcome Treatment
    1