MalfunctionHXY
DRILL BRACE WITHOUT CHUCK ORIGINAL HOFFMANN
Received Oct 25, 2011 · Event occurred Oct 3, 2011
Report 8031020-2011-00231 · MDR key 2337941
Device
Generic name
Instrument
Manufacturer
Stryker Osteosynthesis SelzachModel number
NACatalog number
5054-2-002
Lot number
J373852
Product problems
- Break
Patient
UNK
- No Information
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
DURING EXTERNAL FIXATION SURGERY, THE SURGEON INSERTED APEX PIN IN THE BONE OF THE PT BY USING DRILL BRACE. WHILE THE SURGEON WAS INSERTING THE PIN, THE SCREW (THE CHECK TIGHTENER) AT THE TIP OF DRILL BRACE BROKE. THEREFORE THE SURGERY WAS COMPLETED BY USING ANOTHER DEVICE.
Remedial action
- Other