FDA Adverse Event Malfunction Summary report: N

MINI-ACUTRAK

MDR report key: 1153763 · Received August 27, 2008

Report

Report Number
1153763
Event Type
Malfunction
Date Received
August 27, 2008
Date of Event
August 18, 2008
Report Date
August 27, 2008
Manufacturer
ACUMED LLC
Product Code
HXX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

PATIENT'S OPERATION WAS A SCAPHOID FRACTURE ORIF. THE SINGLE SCREW REQUIRED FOR FIXATION WAS BEING SCREWED INTO THE SCAPHOID BONE BY HAND WHEN THE SCREWDRIVER END BROKE OFF WITHIN THE SCREW. AS A RESULT, THE SCREW WAS LEFT APPROXIMATELY 1MM PROUD FROM THE BONE CORTEX AND WAS UNABLE TO BE REMOVED OR PUT IN ANY FURTHER DUE TO THE VERY SMALL AMOUNT LEFT OUTSIDE THE BONE. A NEW SCREWDRIVER COULD NOT BE USED TO FURTHER ADVANCE THE SCREW BECAUSE OF THE BROKEN PIECE LEFT IN THE SCREW HEAD BY THE PREVIOUS SCREWDRIVER. SO 1) THE FIXATING SCREW WAS LEFT ABOUT 1MM PROUD FROM THE SCAPHOID BONE PROXIMALLY, AND 2) A SMALL FOREIGN BODY IS PRESENT IN THE PATIENT WHICH IS THE TINY PIECE OF SCREWDRIVER THAT BROKE OFF WITHIN THE SCREW HEAD. IT IS POSSIBLE THAT THE PORTION OF SCREW LEFT PROUD COULD GOUGE OR PRESS AGAINST THE PATIENT'S DISTAL RADIUS UPON EXTREME FLEXION OF THE WRIST. THE PATIENT LEFT THE HOSPITAL UNAWARE OF THIS SITUATION POST-OP AND WE HAVE BEEN UNABLE TO CONTACT THE PATIENT BY PHONE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MINI-ACUTRAK SCREWDRIVER, ORTHOPEDIC HXX ACUMED LLC HD-1509 *

Patients

Seq Age Sex Outcome Treatment
1 29 YR