BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR

    MDR report key: 1203757 · Received October 10, 2008

    Report

    Report Number
    1822565-2008-00690
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE POST MAY HAVE FRACTURED DUE TO HIGH, REPEATED IMPACTION FORCES. TO POTENTIALLY IMPROVE PERFORMANCE, THE MATERIAL SPECIFIED HAS SINCE BEEN CHANGED TO 13-8 SST, WHICH IS LESS NOTCH SENSITIVE. THIS IMPACTOR DEVICE WAS MANUFACTURED FROM 455 SST, WHICH WAS PRIOR TO MATERIAL CHANGES. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. THE 6MM CANNULATED DRILL IS FRACTURED ALONG ITS WELD JOINT. THIS MAY HAVE OCCURRED DUE TO HIGH, REPEATED BENDING FORCES. THE EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION CODES: RESULTS AND CONCLUSIONS- AS RETURNED, THE LINER IMPACTOR EXHIBITS FRACTURE AT THE BASE OF THE POST. THE DEVICE MANUFACTURING RECORDS ARE INTACT AND CONFORMING, INDICATING THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING SURGERY IN 2008, THE CANNULATED DRILL BROKE WHEN THE SURGEON WAS DRILLING THE GLENOID. ALSO, THE IMPACTOR BROKE WHILE HE WAS IMPACTING THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION LINER IMPACTOR SHOULDER INSTRUMENT HWA ZIMMER, INC. NA 60915146

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DRILL WITH STOP| TRABECULAR METAL GLENOID INSTRUMENT CANNULATED| CATALOG #47430706100| BIGLINAI/FLATOW THE COMPLETE SHOULDER SOLUTION