MalfunctionLXI
PASSPORT A/R FEM. ALIGN. GUIDE
Received May 24, 2010 · Event occurred May 11, 2010
Report 2249697-2010-00580 · MDR key 1701372
Device
Generic name
Instrument
Manufacturer
Stryker Orthopaedics MahwahModel number
NACatalog number
7650-5901
Lot number
RD4N219
Product problems
- Device Slipped
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
SCORPIO REPLACEMENT INSTRUMENT ISSUE: THE ANTERIOR SKIM CUTTING GUIDE WAS LOOSE IN THE A/R FEMORAL ALIGNMENT GUIDE AND WAS UNABLE TO BE TIGHTENED TO HOLD. REPLACEMENT INSTRUMENTS BEING USED FOR THE FIRST TIME.
Remedial action
- Other