BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM

    MDR report key: 4039876 · Received August 27, 2014

    Report

    Report Number
    1220246-2014-00148
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 30, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. 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. LOT NUMBER WAS NOT PROVIDED, SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. BIO-ABSORBABLE IMPLANTS ARE DESIGNED WITH MATERIAL QUALITIES REQUIRED TO MAINTAIN NECESSARY PROPERTIES THROUGHOUT THE HEALING PROCESS UNDER NORMAL PATIENT CONDITIONS. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A UCL (ULNAR COLLATERAL LIGAMENT) RECONSTRUCTION 2 YEARS AGO WITH PALMARIS LONGUS GRAFT. TENODESIS SCREWS PROXIMAL AND DISTAL, WERE INSERTED IN AN INITIAL SURGERY. THE INITIAL SKI INJURY WAS 3.5 YEARS AGO. A 3-0 FIBERWIRE WAS USED TO DRAW THE GRAFT IN PLACE AND LEFT IN THE DRILL CHANNEL. PATIENT WAS COMPLETELY PAIN FREE UNTIL 6 MONTH AGO WHEN SHE FELT INCREASING PAIN AND INSTABILITY. AN X-RAY SHOWED INCREASING RADIOLUCENCY AROUND PROXIMAL SCREW. IN A REVISION SURGERY, PRE-OPERATIVELY WERE FOUND, A CYST FORMATION AROUND THE AREA OF THE TENODESIS SCREW AS WELL AS FIBERWIRE DEBRIS IN THE CYST. HISTOLOGY SHOWED BONE CYST AND FOREIGN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521919 BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3X 8MM SCREW, FIXATION, BONE HWC ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-7229-20, FIBERLOOP, LOT UNKNOWN.