BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLA

    MDR report key: 3243342 · Received June 25, 2013

    Report

    Report Number
    3008747271-2013-00002
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    February 8, 2013
    Report Date
    June 25, 2013
    Manufacturer
    TOBY ORTHOPAEDICS
    Product Code
    HRS
    PMA / PMN Number
    K081608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS MISTAKENLY NOT REPORTED TO THE FDA AND IS NOW BEING SUBMITTED IN RESPONSE TO AN FDA INSPECTION 483 ITEM. THE (B)(4) SALES DISTRIBUTOR, INITIALLY REPORTED THE INCIDENT TO THE (B)(4) MEDICAL DIRECTOR ON THE DATE NOTED ABOVE. AN INVESTIGATION WAS PERFORMED BY THE (B)(4) MEDICAL DIRECTOR TO DETERMINE IF THE CORRECT SURGICAL PROCEDURE WAS USED AND THE METHOD OF FAILURE FOR THE SUTURE CLIP. THE SURGEONS CONFIRMED THAT THE PLATE SYSTEM PERFORMED AS INTENDED FOR THE SURGERY, OTHER THAN THE BROKEN SUTURE CLIP, AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE MEDICAL DIRECTOR DISCOVERED THAT THE ACTING SURGEON WAS USING A GRADE OF SUTURE WIRE MUCH LARGER THAN THE RECOMMENDED SUTURE (#5 FIBERWIRE), AND WAS ALSO OVER MANIPULATING THE CLIPS DURING THE REDUCTION PROCESS. ONE LEG OF THE SUTURE CLIP BROKE AND THEREFORE THE CLIP BECAME DETACHED FROM THE PLATE. THE (B)(4) MEDICAL DIRECTOR SHARED VALIDATION TEST DATA WITH THE SURGEON, AND ALL PARTIES AGREED THAT #2 ETHIBOND SUTURE WIRE STRENGTH IS MORE THAN ADEQUATE AND SHALL BE USED PER THE (B)(4) PANTERA SYSTEM RECOMMENDATIONS. THE DEVICE MALFUNCTIONS RESULTED IN A MINOR DELAY DURING THE SURGICAL PROCEDURE, BUT OTHERWISE, NO OTHER NEGATIVE IMPACT WAS NOTED DURING THE EVENT.

    Description of Event or Problem · 1

    DURING A HUMERUS FRACTURE FIXATION SURGERY, A PANTERA SUTURE CLIP BROKE FROM EXCESSIVE MANIPULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287217 PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLA BONE PLATE HRS TOBY ORTHOPAEDICS TO-PANTERA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other