BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON

    MDR report key: 8583552 · Received May 6, 2019

    Report

    Report Number
    1043534-2019-00058
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    June 12, 2015
    Report Date
    April 11, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HXA
    PMA / PMN Number
    K872284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: MCCLEAVE. ULNAR NERVE INJURY AFTER FLEXOR TENDON GRAFTING. THE JOURNAL OF HAND SURGERY. 2016; 21: 425-427. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IN AN ARTICLE WRITTEN BY MCCLEAVE ET AL TITLED "ULNAR NERVE INJURY AFTER FLEXOR TENDON GRAFTING" IT WAS REPORTED THAT THE PATIENT UNDERWENT A TWO-STAGE TENDON RECONSTRUCTION AND DEVELOPED A LOW ULNAR NERVE PALSY POSTOPERATIVELY. EXPLORATION FOUND THAT THE TENDON GRAFT WAS PASSING THROUGH GUYON'S CANAL AND THAT THE ULNAR NERVE WAS DIVIDED. A (B)(6)-YEAR-OLD FEMALE LEFT HAND DOMINANT CHEF CUT HER FINGER WITH A KNIFE AND INITIALLY HAD HER FINGER SUTURED BY HER LOCAL DOCTOR. SHE WAS REFERRED SIX WEEKS LATER TO A HAND SURGEON AT ANOTHER INSTITUTION WITH A LOSS OF SMALL FINGER FLEXION. A DIAGNOSIS OF A RUPTURED FLEXOR DIGITORUM PROFUNDAS (FDP) IN ZONE TWO WAS MADE AND THE PATIENT THEN HAD A TWO-STAGE TENDON RECONSTRUCTION USING A SPLIT FLEXOR CARPI RADIALIS (FCR) TENDON WITH SURGERY TWO MONTH LATER. THE PATIENT THEN HAD A TENOLYSIS NINE MONTHS LATER TO IMPROVE HER FLEXION. THE PATIENT HAD NOTICED NUMBNESS IN THE DISTRIBUTION OF THE ULNAR NERVE IMMEDIATELY AFTER HER FIRST OPERATION. A NERVE CONDUCTION STUDY WAS PERFORMED 12 MONTHS AFTER THE INITIAL SURGERY AND SHOWED A SEVERE ULNAR NERVE NEUROPATHY AT THE LEVEL OF THE WRIST. AN ULTRASOUND STATED THAT THE FDP TENDON TO THE 5TH DIGIT WAS INTACT BUT THINNER THAN THE CONTRALATERAL SIDE. A PALMAR MASS WAS NOTED ON THE VOLAR ASPECT OF THE TENDON AND IT WAS THOUGHT THAT THIS REPRESENTED THE OLD RUPTURED TENDON. NO MENTION WAS MADE OF THE TENDON POSITION WITHIN THE HAND AND WRIST OR ABOUT THE ULNAR NERVE. SHE WAS SUBSEQUENTLY REFERRED TO ME FOR AN OPINION. CLINICALLY A SMALL VOLAR WRIST SCAR WAS NOTED. SHE HAD AN ULNAR CLAW HAND DEFORMITY, SEVERE ULNAR INNERVATED INTRINSIC MUSCLE WASTING AND NUMBNESS OVER THE VOLAR ASPECT OF THE SMALL AND ULNAR HALF OF THE RING FINGER. A LOW ULNAR NERVE INJURY WITHIN GUYON'S CANAL WAS DIAGNOSED. THE SMALL FINGER TENDON GRAFT HAD GOOD FLEXION BUT RESTRICTED EXTENSION. THE PATIENT UNDERWENT AN EXPLORATION THAT EXPOSED THE ULNAR NERVE IN GUYON'S CANAL WITH DISTAL AND PROXIMAL EXTENSION. IT WAS NOTED THAT THE TENDON GRAFT WAS PASSING THROUGH GUYON'S CANAL AND ABLE TO FLEX THE SMALL FINGER. THE ULNAR NERVE WAS DIVIDED AT THE LEVEL OF THE TRIFURCATION. A NEUROMA WAS PRESENT ON THE PROXIMAL NERVE. FIG. 1 SHOWS THE TENDON GRAFT PASSING THROUGH GUYON'S CANAL AND THE DIVIDED ULNAR NERVE. THE TENDON GRAFT WAS DIVIDED PROXIMALLY AND REROUTED UNDER THE DISTAL NEUROVASCULAR BUNDLES AND THROUGH THE CARPAL TUNNEL. IT WAS ATTACHED TO THE RING FINGER FDP TENDON WITH A PULVERTAFT WEAVE. THREE SURAL NERVE GRAFTS WERE USED TO RECONSTRUCT THE ULNAR NERVE. THE PATIENT HAS NOW BEEN FOLLOWED FOR 18 MONTHS AND THE SMALL FINGER HAS A FULL ACTIVE RANGE OF MOTION. TWO POINT DISCRIMINATION IN THE ULNAR NERVE DISTRIBUTION MEASURED 8-10 MM AND ULNAR INNERVATED INTRINSIC FUNCTION IS GRADED AT M3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375638 HUNTER TENDON PROSTHESIS, TENDON, PASSIVE HXA WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention