BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK PUSHLOCK SP, 4.5 MM X 18.5 MM

    MDR report key: 1241273 · Received November 21, 2008

    Report

    Report Number
    1220246-2008-00238
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE, THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE LOT NUMBER WAS REQUESTED BUT UNKNOWN/NOT PROVIDED, THEREFORE DEVICE HISTORY RECORD AND COMPLAINTS HISTORY REVIEWS COULD NOT BE CONDUCTED. NOT ENOUGH INFORMATION WAS PROVIDED IN ORDER TO DETERMINE A MOST LIKELY CAUSE FOR THIS EVENT DESCRIPTION. IF THE DEVICE IS RETURNED AND/OR ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN DURING REHAB OF A ROTATOR CUFF REPAIR THAT WAS PERFORMED IN 2008. AN MRI WAS TAKEN AND A REMOVAL SURGERY WAS COMPLETED FOUR MONTHS LATER. THE TIP WAS RETRIEVED BUT THE BODY OF THE IMPLANT COULD NOT BE LOCATED. THE SURGEON THOUGHT THE IMPLANT WENT THROUGH THE HUMERUS AND INTO THE JOINT. FOLLOW UP WITH THE SURGEON PROVIDED INFORMATION THAT THE ANCHOR WAS STABLE- A METAL PIECE WITH FIBER WIRE PENETRATED ALL THE WAY INTO THE GLENOHUMERAL JOINT. THE PATIENT HAD COMPLAINED OF POST-OP STIFFNESS. X-RAY WAS TAKEN. LOOSE BODY IDENTIFIED. SURGEON WENT BACK IN FOR SECOND SURGERY TO RETRIEVE LOOSE BODY. WHILE IN THE SHOULDER, HE EXPLORED THE ROTATOR CUFF. ADHESIONS WERE FOUND IN SUBACROMIAL SPACE; THEY WERE LOOSENED. THE PATIENT'S STIFFNESS WAS RESOLVED, RCR WAS FINE, PATIENT FEELS BETTER. LOT NUMBER WAS REQUESTED BUT NOT PROVIDED/UNAVAILABLE. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATIONS. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK PUSHLOCK SP, 4.5 MM X 18.5 MM HWC ARTHREX, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R INFORMATION REQUESTED BUT NOT PROVIDED