GARDNER-WELLS TRACTION TONGS COMPLETE
Received Dec 2, 2011 · Event occurred Oct 26, 2011
Report 1423507-2011-00019 · MDR key 2356800
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Death
- Perforation
- Brain Injury
Narrative
Description of Event or Problem
SALES REP REPORTS BEING TOLD ON APPROXIMATELY (B)(6) 2011 THAT THERE WAS AN INCIDENT DURING APPLICATION OF THE HALO INVOLVING THE SCREW NOT FUNCTIONING PROPERLY. THE SCREW "MALFUNCTIONED". THE SCREW IS DESCRIBED AS SPRING-LOADED. ON (B)(6) 2011, SALES REP REPORTS BECOMING AWARE THAT A DEATH OCCURRED AS THE RESULT OF THE SCREW BEING TIGHTENED TO THE POINT OF GOING THROUGH THE SKULL AND ENTERING THE PATIENTS BRAIN. THE ACTUAL DETAILS ARE SKETCHY. SALES REP DOES NOT HAVE THE CLINICIAN'S NAME. SALES REP WAS TOLD THAT THE INSTRUMENT WAS DISCARDED AFTER THE PROCEDURE. THERE IS NO SAMPLE AVAILABLE. THE INSTRUMENT IS MANUFACTURED BY INSTRUMED. SALES REP REPORTS HE HAS REACHED OUT TO INSTRUMED TO TRY TO OBTAIN THE IFU WITH NO RESPONSE. USER FACILITY HAS REQUESTED DOCUMENTATION OF TESTING ON THE SPRING LOADED SCREW FROM THE MANUFACTURER. ADDITIONAL INFORMATION OBTAINED. ON (B)(6) 2011 THE SALES REP WAS MADE AWARE BY THE USER FACILITY THAT THERE WAS IN FACT NO DEATH AS A RESULT OF THE INCIDENT. THE SALES REP WAS ALSO MADE AWARE THAT THE INSTRUMENT HAD INADVERTENTLY BEEN DISCARDED. THE SALES REP WAS NOT PROVIDED ANY ADDITIONAL INFORMATION AT THE TIME.
Additional Manufacturer Narrative
(B)(4). THE COMPLAINT SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. TO DATE, THE INITIAL REPORTER HAS NOT RESPONDED TO CAREFUSION'S REQUESTS FOR ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
ON (B)(6) 2012, THE CUSTOMER PROVIDED ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE PHYSICIAN PLACED THE GARDNER-WELLS TRACTION TONGS ON THE PATIENT AND NOTICED THAT THE SCREWS WERE NOT FUNCTIONING PROPERLY. THE INSTRUMENT WAS REMOVED AND A NEW GARDNER-WELLS TRACTION TONGS INSTRUMENT WAS USED FOR THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTICED A SUBDURAL HEMATOMA ON THE PATIENTS HEAD. IT WAS BELIEVED THAT THIS WAS CAUSED BY THE FIRST INSTRUMENT USED ON THE PATIENT. UNFORTUNATELY THIS INSTRUMENT WAS WRAPPED UP AFTER ITS USE AND INADVERTENTLY DISCARDED. THE LOT NUMBER FROM THE INSTRUMENT IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE CUSTOMER.