BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM TRIAL, 14MM

    MDR report key: 5258626 · Received December 1, 2015

    Report

    Report Number
    1651501-2015-00040
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Report Date
    November 6, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K152047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 4FEB2016. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: THE REVIEW OF THE MANUFACTURING RECORD FOR LOT NUMBER 201274-9, CMR# FOR NONCONFORMITIES PRODUCT RECEIPT OR BY THE SUPPLIERS PERFORMING MANUFACTURING OPERATIONS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT ALLEGATION. THE COMPLAINT RATE WAS CALCULATED BASED ON THE NUMBER OF DEVICES AFFECTED BY THE HAZARDOUS SITUATION OR FAILURE MODE, OVER THE NUMBER OF SURGERIES OR UNITS SOLD DURING THE PERIOD OF THE REVIEW. FROM 2013 TO PRESENT, THERE HAVE BEEN A TOTAL OF (B)(4) COMPLAINTS ABOUT THE HUMERAL STEM TRIAL, 9MM ¿ 14MM WITH THE FAILURE MODE OF THE DEVICE BREAKING. (B)(4). CONCLUSION: ROOT CAUSE ANALYSIS CONCLUSION: SELF-LOOSENING (CLAMPING FORCE INSTABILITY); IMPACT INDUCED VIBRATION ¿ THE COMMON CAUSE FOR SELF-LOOSEN DUE TO JOINT STRENGTH LOSS AND BOLT OVERLOAD IMPACT-INDUCED VIBRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE BROKE DURING A PROCEDURE. THE TRIAL SOUND BROKE ON REMOVING FROM CANAL AT HANDLE/TRIAL INTERFACE. THE STEM TRIAL WAS INSIDE OF THE PATIENT'S HUMERAL CANAL AND THE SURGEON WAS IN THE PROCESS OF REMOVING THE ASSEMBLED STEM TRIAL AND HANDLE CONSTRUCT WHEN THE BREAKAGE OCCURRED. THE THREADS OF THE TRIAL BROKE OFF AND WERE LODGED INSIDE THE HANDLE. THE SURGEON WAS ABLE TO REMOVE THE TRIAL WITH A HIP SLAPHAMMER LOCATED FROM ANOTHER SET WITHIN THE HOSPITAL. THE SURGEON INDICATED THAT THIS BREAKAGE ADDED AN HOUR TO THE PROCEDURE, BUT HE WAS ABLE TO COMPLETE THE OPERATION. THE PROCEDURE WAS COMPLETED AS INTENDED AND THE SURGEON DOES NOT EXPECT THIS EVENT TO ADVERSELY AFFECT THE PATIENT. IT WAS REPORTED NO PATIENT INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790015 HUMERAL STEM TRIAL, 14MM TITAN TOTAL SHOULDER INSTRUMENTS KWS ASCENSION ORTHOPEDICS 201274-9

    Patients

    Seq Age Sex Outcome Treatment
    1