BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON

    MDR report key: 11528711 · Received March 19, 2021

    Report

    Report Number
    1043534-2021-00044
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    January 1, 2019
    Report Date
    April 21, 2021
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    PMA / PMN Number
    K872285
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: MEGUMI FUJITA ET AL. CONTINUOUS CATHETER IRRIGATION FOR THE TREATMENT OF PURULENT TENOSYNOVITIS DURING TWO-STAGE FLEXOR TENDON RECONSTRUCTION. J HAND MICROSURG 2019;11:170-174. H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES WERE PROVIDED IN THE LITERATURE. MAGNETIC RESONANCE IMAGING AT THE INITIAL EXAMINATION SHOWED LOW SIGNAL ON THE AXIAL T1-WEIGHTED IMAGES AND HIGH SIGNAL ON THE SAGITTAL T2-WEIGHTED AND FAT-SUPPRESSED T2-WEIGHTED IMAGES AROUND AND FLEXOR TENDON. MRI ALSO SHOWED BOWSTRINGING OF THE FLEXOR TENDON ON SAGITTAL T2-WEIGHTED IMAGES. PHYSICAL EXAMINATION BEFORE OPERATION FOUND THE INFECTION SUBSIDED AND THE WOUND EPITHELIALIZED, BUT FLEXION CONTRACTURE OF THE MIDDLE FINGER REMAINED DUE TO MARKED BOWSTRINGING OF THE FLEXOR TENDON, AT EXTENSION AND FLEXION. IMAGES OF RANGE OF MOTION AT 1 YEAR AFTER THE OPERATION. THE DISTAL INTERPHALANGEAL JOINT HAD REMAINING EXTENSION LAG, BUT THE PROXIMAL INTERPHALANGEAL AND THE METACARPOPHALANGEAL JOINTS ACHIEVED A GOOD RANGE OF MOTION, AT EXTENSION AND FLEXION.

    Description of Event or Problem · 0

    ALLEGEDLY IT WAS REPORTED BY FUJITA ET AL IN AN ARTICLE TITLED, "CONTINUOUS CATHETER IRRIGATION FOR THE TREATMENT OF PURULENT TENOSYNOVITIS DURING TWO-STAGE FLEXOR TENDON RECONSTRUCTION" THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. ALLEGEDLY, THE PATIENT DEVELOPED AN INFECTION AROUND THE DEVICE APPROXIMATELY 45 DAYS POST-OP WITH "PURULENT DISCHARGE DEVELOPED IN THE WOUND AT THE FINGER APEX, WITH S. AUREUS DETECTED ON BACTERIAL CULTURE. SUBSEQUENT TREATMENT WITH WOUND IRRIGATION AND ANTIBIOTICS FAILED TO IMPROVE THE CONDITION. AT 80 DAYS AFTER THE FIRST-STAGE OPERATION, WE REMOVED THE SILICONE ROD, INSERTED A CATHETER PREPARED BY PUNCHING MULTIPLE PORES ON A POLYVINYL CHLORIDE TUBE 2.7 MM IN OUTER DIAMETER AS A REPLACEMENT, AND INITIATED CONTINUOUS CATHETER IRRIGATION. WE PERFORMED CONTINUOUS IRRIGATION USING 2,000 ML/DAY OF PHYSIOLOGIC SALINE FOR 10 DAYS. NEGATIVE BACTERIAL CULTURE WAS CONFIRMED FROM LAVAGE FLUID TAKEN AFTER 5 DAYS OF CONTINUOUS IRRIGATION. WE REMOVED THE CATHETER AT 12 DAYS AFTER THE START OF CONTINUOUS IRRIGATION AND PERFORMED THE SECOND-STAGE TENDON GRAFT SURGERY, USING A TOE EXTENSOR TENDON AS THE GRAFT. POSTOPERATIVE THERAPY WAS INITIATED WITH PASSIVE FLEXION AND ACTIVE EXTENSION 1 WEEK AFTER THE OPERATION, AND ACTIVE FLEXION WAS ALLOWED FROM 3 WEEKS AFTER THE OPERATION. AS OF 1 YEAR AFTER SURGERY, INFECTION HAS NOT RELAPSED."

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MEGUMI FUJITA ET AL. CONTINUOUS CATHETER IRRIGATION FOR THE TREATMENT OF PURULENT TENOSYNOVITIS DURING TWO-STAGE FLEXOR TENDON RECONSTRUCTION. J HAND MICROSURG 2019;11:170-174. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ALLEGEDLY IT WAS REPORTED BY FUJITA ET AL IN AN ARTICLE TITLED, "CONTINUOUS CATHETER IRRIGATION FOR THE TREATMENT OF PURULENT TENOSYNOVITIS DURING TWO-STAGE FLEXOR TENDON RECONSTRUCTION" THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. ALLEGEDLY, THE PATIENT DEVELOPED AN INFECTION AROUND THE DEVICE APPROXIMATELY 45 DAYS POST-OP WITH "PURULENT DISCHARGE DEVELOPED IN THE WOUND AT THE FINGER APEX, WITH S. AUREUS DETECTED ON BACTERIAL CULTURE. SUBSEQUENT TREATMENT WITH WOUND IRRIGATION AND ANTIBIOTICS FAILED TO IMPROVE THE CONDITION. AT 80 DAYS AFTER THE FIRST-STAGE OPERATION, WE REMOVED THE SILICONE ROD, INSERTED A CATHETER PREPARED BY PUNCHING MULTIPLE PORES ON A POLYVINYL CHLORIDE TUBE 2.7 MM IN OUTER DIAMETER AS A REPLACEMENT, AND INITIATED CONTINUOUS CATHETER IRRIGATION. WE PERFORMED CONTINUOUS IRRIGATION USING 2,000 ML/DAY OF PHYSIOLOGIC SALINE FOR 10 DAYS. NEGATIVE BACTERIAL CULTURE WAS CONFIRMED FROM LAVAGE FLUID TAKEN AFTER 5 DAYS OF CONTINUOUS IRRIGATION. WE REMOVED THE CATHETER AT 12 DAYS AFTER THE START OF CONTINUOUS IRRIGATION AND PERFORMED THE SECOND-STAGE TENDON GRAFT SURGERY, USING A TOE EXTENSOR TENDON AS THE GRAFT. POSTOPERATIVE THERAPY WAS INITIATED WITH PASSIVE FLEXION AND ACTIVE EXTENSION 1 WEEK AFTER THE OPERATION, AND ACTIVE FLEXION WAS ALLOWED FROM 3 WEEKS AFTER THE OPERATION. AS OF 1 YEAR AFTER SURGERY, INFECTION HAS NOT RELAPSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429452 HUNTER TENDON PROSTHESIS, TENDON, PASSIVE HXA WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention