BEUDAMED
    FDA Adverse Event Other Summary report: N

    PORTABLE DISTRACTION DEVICE

    MDR report key: 171895 · Received June 8, 1998

    Report

    Report Number
    2952369-1998-00003
    Event Type
    Other
    Date Received
    June 8, 1998
    Date of Event
    May 11, 1998
    Report Date
    June 1, 1998
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    HST
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING HIP ARTHROSCOPY SURGERY OF ARTHRITIC 65 Y.O. MALE, THE GEAR THAT ALLOWS VARUS/VALGUS ADJUSTMENT FAILED, CAUSING THE WIRE TENSIONER TO SLIP INTO THE VARUS ORIENTATION AND THE K-WIRE TO CUT INTO SOME OF THE MEDIAL OSTEOPOROTIC BONE. ACCORDING TO THE SURGEON, NO PERMANENT INJURY OCCURRED, BUT SURGICAL INTERVENTION WAS REQUIRED IN ORDER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTABLE DISTRACTION DEVICE NONPOWERED ORTHOPEDIC 888.5850 TRACTION APPARATUS HST HAYES MEDICAL, INC. 1001-0079 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other INCIDENT OCCURRED DURING HIP ARTHROSCOPY SURGERY.