BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUNTER TENDON

    MDR report key: 8582921 · Received May 6, 2019

    Report

    Report Number
    1043534-2019-00057
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    April 1, 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
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CURRAN ET AL. "IATROGENIC MEDIAN NERVE COMPRESSION WITH A SILICONE ROD: A CASE REPORT AND REVIEW OF THE LITERATURE." PLAST SURG CASE STUDIES. 2015; 01: 5-6

    Description of Event or Problem · 1

    ALLEGEDLY, IT WAS REPORTED IN A LITERATURE ARTICLE BY CURRAN ET AL. TITLED "IATROGENIC MEDIAN NERVE COMPRESSION WITH A SILICONE ROD: A CASE REPORT AND REVIEW OF THE LITERATURE" THAT A CASE STUDY OF A TENDON ROD USED IN A TWO STAGE FLEXOR TENDON RECONSTRUCTION SURGERY THAT CAUSED MEDIAN NERVE DAMAGE IN THE PATIENT. IN THIS CASE, THE SECOND STAGE OF THE SURGERY HAD NOT BEEN PERFORMED AND THE DEVICE WAS LEFT IN AND MIGRATED. A (B)(6) RIGHT HAND DOMINANT BUTCHER PRESENTED TO THE AUTHOR'S SERVICES WITH A THREE-MONTH HISTORY OF ACUTE-ONSET OF PARAESTHESIA IN THE MEDIAN NERVE DISTRIBUTION OF HIS RIGHT HAND. THE SYMPTOMS BEGAN AFTER A SERIES OF REPEATED PUMPING EXERCISES OF THE HAND. THE PARAESTHESIA WAS EXACERBATED BY WORK AND WAS PARTICULARLY SEVERE AT NIGHT. HIS GENERAL PRACTITIONER HAD REFERRED HIM FOR NERVE CONDUCTION STUDIES, WHICH REVEALED MODERATELY PROLONGED DISTAL LATENCY WITH MARKEDLY REDUCED AMPLITUDE IN THE MEDIAN NERVE. HE WAS THUS REFERRED TO THE PLASTIC SURGERY SERVICE FOR FURTHER MANAGEMENT. ON EXAMINATION, HE HAD A POSITIVE TINEL'S SIGN AND PHALEN'S SIGN. IT WAS NOTED THAT HE HAD A SCAR AT THE PROXIMAL PHALANX OF HIS LITTLE FINGER AND AT THE WRIST ON THE ULNAR ASPECT. ON EXAMINATION, THERE WAS NO ACTIVE FLEXION OF THIS FINGER. THE PATIENT EXPLAINED THAT HE HAD SUSTAINED A KNIFE LACERATION TO THE LITTLE FINGER FIVE YEARS PREVIOUSLY AND THAT BOTH FLEXOR TENDONS HAD BEEN DIVIDED. HE UNDERWENT A PRIMARY TENDON REPAIR OF THE FLEXOR DIGITORUM PROFUNDUS (FDP) IN HIS NATIVE LITHUANIA. THE FLEXOR DIGITORUM SUPERFICIALIS TENDON TO THE DIGIT WAS NOT REPAIRED. UNFORTUNATELY, THE REPAIR RUPTURED FOUR WEEKS LATER AND A SILICONE ROD WAS INSERTED TO FACILITATE A TWO-STAGE RECONSTRUCTION OF THE FDP TENDON. THE PATIENT FAILED TO ATTEND FOR THE SCHEDULED SECOND STAGE SURGERY AND, SHORTLY AFTERWARD, RELOCATED TO IRELAND. THE LOSS OF FUNCTION IN THE LITTLE FINGER HAD NOT CONCERNED HIM SIGNIFICANTLY AND HE WAS ABLE TO PERFORM HIS DUTIES AS A BUTCHER. HE WAS SCHEDULED FOR CARPAL TUNNEL DECOMPRESSION UNDER LOCAL ANAESTHETIC. DURING EXPLORATION, A CONSIDERABLE DEGREE OF SYNOVIAL THICKENING WAS EVIDENT AND A SILICONE ROD WAS FOUND CURLED UNDER THE MEDIAN NERVE. THE ROD WAS REMOVED AND A LOCALIZED FLEXOR SYNOVECTOMY WAS PERFORMED IN ADDITION TO A CARPAL LIGAMENT RELEASE. FOLLOWING HIS CARPAL TUNNEL DECOMPRESSION, HE WAS REVIEWED IN THE OUTPATIENT CLINIC AT TWO WEEKS AND SIX WEEKS POSTOPERATIVELY, AND WAS SHOWING SIGNS OF RECOVERY OF SENSATION TO THE INDEX FINGER AND RELIEF OF THE PARAESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377623 HUNTER TENDON PROSTHESIS, TENDON, PASSIVE HXA WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention