FDA Adverse Event Malfunction Summary report: N

JACKSON TABLE

MDR report key: 1701959 · Received May 21, 2010

Report

Report Number
1701959
Event Type
Malfunction
Date Received
May 21, 2010
Date of Event
April 19, 2010
Report Date
May 7, 2010
Manufacturer
MIZUHO OSI
Product Code
JEA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

THE PATIENT WAS ON THE JACKSON FRACTURE TABLE WITH HIS RIGHT LEG SECURED TO THE TABLE WITH THE TRACTION PIN AND APPROPRIATE TABLE ATTACHMENT (KIRSCHNER BOW HOLDER). WHEN THE CIRCULATOR WAS ASKED BY THE MD TO INCREASE THE TRACTION ON THE AFFECTED LIMB, A COMPONENT OF THE VISE PORTION OF THE HOLDER CAME LOOSE DUE TO CRACKED WELDS THEREBY RELEASING THE AFFECTED LEG. THE MD CAUGHT THE LEG AND SUPPORTED IT BY PLACING IT ON A PADDED MAYO STAND. MD THEN ASKED THE CIRCULATOR TO HANG 90 POUNDS OF WEIGHT TO PUT THE AFFECTED LEG BACK IN TRACTION. SEVERAL INTRAOPERATIVE XRAYS WERE TAKEN TO CONFIRM NO FURTHER DAMAGE HAD RESULTED AND THAT REDUCTION OF THE FRACTURE WAS OPTIMAL. CASE RESUMED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE VISE PORTION OF THE KIRSCHNER BOW HOLDER HAS TWO OPPOSING PLATES SEPARATED BY A FIXED DISTANCE, ABOUT 1CM. BOTH PLATES ARE WELDED TO A SOLID BASEPLATE THAT IS ITSELF ATTACHED TO A TUBULAR PART OF THE MAIN TABLE. THE HOLDER HAS A BLUE HANDLE FOR ADJUSTING THE POSITION OF THE VISE WITH RESPECT TO THE BASEPLATE AND A RED HANDLE FOR ADJUSTING THE ANGLE OF THE BASEPLATE WITH RESPECT TO THE TABLE. THE LEG PIN IS FASTENED TO THE VISE BY MEANS OF A THUMBSCREW. THE THREE WELDS HOLDING THE 3CM X 5CM X 0.8CM PLATE WERE CRACKED ALL THE WAY THROUGH. WHAT WAS SURPRISING IS THAT ONE OF THE WELDS IS POSITIONED SO THAT FORCE APPLIED BY THE THUMBSCREW CAN TILT THE PLATE BACKWARD AND FATIGUE THE WELD.====================== MANUFACTURER RESPONSE FOR ORTHOPAEDIC OR TABLE ACCESSORY, JACKSON FRACTURE TABLE======================NO RESPONSE AT THIS TIME OTHER THAN INTEREST IN ANALYZING THE PART THAT BROKE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 JACKSON TABLE ORTHOPEDIC TABLE ACCESSORY JEA MIZUHO OSI 5862 *

Patients

Seq Age Sex Outcome Treatment
1 36 YR NO OTHER THERAPIES