MalfunctionLRZ
CAPTIVE HEX SCREWDRIVER
Received Sep 20, 2004 · Event occurred Aug 25, 2004
Report 1057469-2004-00005 · MDR key 5303354
Device
Generic name
Screwdriver
Manufacturer
Endius, Inc.Model number
NACatalog number
ET 1052-01
Lot number
L526718
Product problems
- Break
- Difficult to Remove
- Device Or Device Fragments Location Unknown
Patient
22 YR
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
A CAPTIVE HEXTIP SCREWDRIVER BROKE WHILE THE SURGEON WAS TIGHTENING THE LAST CAP SCREW OF A SPINAL FIXATION SYSTEM. THE SURGEON ATTEMPTED TO REMOVE THE HEX TIP FROM THE CAP SCREW UNSUCCESSFULLY. THE TIP OF THE SCREWDRIVER REMAINED EMBEDDED IN THE CAPSCREW AND THE PATIENT WAS CLOSED. THE SCREWDRIVER IS MANUFACTURED WITH 440C STAINLESS STEEL BUT HAS NOT BEEN USED FOR IMPLANTS. THE CAPSCREW IS MADE FROM TITANIUM. THERE IS A POSSIBILITY OF INTERACTION/CORROSION DUE TO THE IMPLANTATION OF THESE DISSIMILAR METALS.