BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE

    MDR report key: 3243339 · Received June 25, 2013

    Report

    Report Number
    3008747271-2013-00001
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 6, 2012
    Report Date
    June 25, 2013
    Manufacturer
    TOBY ORTHOPAEDICS
    Product Code
    HRS
    PMA / PMN Number
    K081608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MISTAKENLY REPORTED ON THE FORM 3500 VOLUNTARY EVENT REPORTING DOCUMENT ON (B)(4) 2012, AND IS NOW BEING RESUBMITTED IN RESPONSE TO AN FDA INSPECTION 483 ITEM. A TOBY SALES REP INITIALLY REPORTED THE INCIDENT TO THE TOBY MEDICAL DIRECTOR ON THE DATE NOTED ABOVE. THE TOBY MEDICAL SPOKE WITH THE ACTING SURGEON AND WAS INFORMED THAT THE PANTERA PLATE SCREW HAD LOST FIXATION ON THE DISTAL PORTION OF THE SHAFT. THE CAUSE OF THE MALFUNCTION WAS THOUGHT TO BE A TRAUMATIC EVENT BECAUSE THERE WERE NO SIGNS OF FATIGUE OR SIGNS OF A GRADUAL LOSS OF FIXATION. IN ADDITION, THE FIXATION AT THE HUMERAL HEAD WAS STILL PERFECTLY INTACT, WHICH DID NOT SEEM NORMAL TO THE MEDICAL EXPERTS. HOWEVER, IT WAS NOTED THAT THE PT STATED THAT SHE DID NOT FALL OR CAUSE TRAUMA TO THE IMPLANT AREA TO CAUSE THE MALFUNCTION, AND IT WAS ALSO NOTED BY THE SURGEON THAT THE PT HAD VERY OSTEOPOROTIC BONE IN THE FRACTURE AREA. THE PLATE WAS EXAMINED AT THE HOSPITAL FACILITY AND WAS DISCARDED BY THE SURGICAL STAFF PRIOR TO ANY POTENTIAL INVESTIGATION TAKING PLACE BY TOBY. THE SURGEON AND SALES REP SAID THAT THERE WERE NO SIGNS OF DAMAGE TO THE DEVICE, ONLY THAT THE DISTAL SCREWS HAD MIGRATED AWAY FROM THE DIAPHYSIS. NO LONG TERM PT INJURY OR DISCOMFORT WAS NOTED.

    Description of Event or Problem · 1

    DISTAL SCREW FIXATION FAILED. MEDICAL EXPERTS AGREED THAT THE CAUSE WAS LIKELY A TRAUMA EVENT/FALL, BUT THE PT SAID THAT NO TRAUMA OCCURRED. PROXIMAL FIXATION INTO THE HUMERAL HEAD REMAINED INTACT, BUT REVISION SURGERY WAS REQUIRED DUE TO THE LOSS OF FIXATION IN THE DISTAL LOCKING SCREWS FROM THE SHAFT. THE DEVICE WAS INTACT AND SHOWED NO SIGNS OF FATIGUE OR FRACTURE. THE BONE ITSELF, MORE SPECIFICALLY, THE SCREW-BONE INTERFACE (ALONG THE DIAPHYSIS) FAILED MOST LIKELY FROM A COMBINATION OF SEVERE OSTEOPOROSIS AND TRAUMA. THE DEVICE WAS NOT AVAILABLE FOR TESTING AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287216 PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE BONE PLATE HRS TOBY ORTHOPAEDICS TO-PANTERA 11001228021

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention