BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERAL STEM TRIAL, 14MM

    MDR report key: 5257526 · Received December 1, 2015

    Report

    Report Number
    1651501-2015-00038
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Report Date
    November 3, 2015
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K130050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT INVOLVES 2 DEVICES, SAME PATIENT, SAME PROCEDURE. THIS IS REPORT 1 OF 2. MFR REPORT NUMBERS: 1651501-2015-00038; 1651501-2015-00039. INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 22FEB2016. 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 REVIEW DID FIND (B)(4) LOTS THAT WERE SUSPECT IN NOT MEETING SPECIFICATIONS FOR THREADING ATTRIBUTES. ALL OTHER PRODUCT LOTS SATISFIED THE APPLICABLE MANUFACTURING SPECIFICATIONS. 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

    THIS REPORTED EVENT INVOLVES 2 DEVICES, SAME PATIENT, SAME PROCEDURE. THIS IS REPORT 1 OF 2. IT WAS REPORTED THAT DURING THE PREPARATION OF THE HUMERAL CANAL FOR A REVERSE SHOULDER ARTHROPLASTY, THE HUMERAL STEM TRIAL BROKE OFF OF STEM TRIAL HANDLE AND WAS LODGED IN THE PATIENT铠HUMERAL CANAL. THE SURGEON WAS ABLE TO RETRIEVE THE STEM TRAIL WITH THE USE OF A VICE GRIP INSTRUMENT. IT WAS REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787323 HUMERAL STEM TRIAL, 14MM TITAN TOTAL SHOULDER INSTRUMENTS KWS ASCENSION ORTHOPEDICS 201274-9

    Patients

    Seq Age Sex Outcome Treatment
    1