TRINICA ATO
Received Jul 28, 2009 · Event occurred Feb 26, 2007
Report 2184052-2009-00044 · MDR key 1485826
Device
Generic name
Swivel Drill Guide
Manufacturer
Zimmer Spine, Inc.Model number
07.00796.001Catalog number
07.00796.001
Lot number
P050893
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
WHEN ATTACHING THE DRILL GUIDE TO THE PLATE, THE DISTAL PIN WHICH SEATS IN THE PLATE BROKE OFF. THE BROKEN PIECE WAS RETRIEVED. A DIFFERENT DRILL GUIDE FROM THE SET WAS USED TO COMPLETE THE CASE. LESS THAN 10 MINUTES WAS ADDED TO SURGERY TIME.
Additional Manufacturer Narrative
DEVICE HISTORY RECORD REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THIS MDR IS BEING SUBMITTED LATE AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES CONDUCTED IN-CONJUNCTION WITH IMPLEMENTATION OF REVISED MDR REPORTING CRITERIA FOR ZIMMER.