DRILL GUIDE WITH GRADUATION
Received Aug 5, 2010 · Event occurred Mar 18, 2008
Report 1719045-2010-00199 · MDR key 1804895
Device
Generic name
Drill Guide
Manufacturer
Synthes MonumentModel number
NACatalog number
388.393
Lot number
575299F07
Product problems
- Device Slipped
Patient
NI
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
INFORMATION INITIALLY REPORTED TO SYNTHES ON (B)(6) 2008 AND WAS DETERMINED TO BE NOT REPORTABLE. ON (B)(6) 2010, SYNTHES PERFORMED A COMPLAINT HISTORY REVIEW AND UPDATED THE COMPLAINT TO REPORTABLE BASED ON THE COMPLAINT TREND. DATE OF THIS REPORT BASED ON THE DATE OF THE COMPLAINT HISTORY REVIEW. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THIS LOT AND NO COMPLAINT RELATED ANOMALIES WERE FOUND. THE STEM ASSEMBLY WAS CONFIRMED TO BE SLIPPING. DURING INVESTIGATION, IT WAS FOUND THAT THE DETENT AND THE PLUNGER SPRINGS WERE UNDERSIZED. IT WAS ALSO FOUND THAT THE DETENT AND PLUNGER SPRINGS WERE SWAPPED IN POSITION FROM THE MANUFACTURING SPECIFICATIONS. AS A RESULT, A CORRECTIVE ACTION WAS OPENED TO UPDATE THE DETAILED ASSEMBLY INSTRUCTIONS.
Description of Event or Problem
SURGEON WAS DRILLING WITH THE DRILL GUIDE WITH GRADUATION AND THE SLEEVE KEPT PUSHING DOWN DURING CERVICAL THORACIC FUSION. SURGEON NOTICED THAT THE LATCH WAS LOOSE. SURGEON COMPLETED THE PROCEDURE BY KEEPING HIS THUMB ON THE SLEEVE.