InjuryHTT
3.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B
Received Apr 9, 2008 · Event occurred Mar 10, 2008
Report 2648666-2008-00038 · MDR key 1027884
Device
Generic name
Small-joint Bur
Manufacturer
Stryker Endoscopy Puerto RicoCatalog number
0375647000
Lot number
UNK
Product problems
- Device, or device fragments remain in patient
- Metal Shedding Debris
Patient
UNK
- Swelling
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
SURGERY WAS PERFORMED ON A PT FROM THE U.S. MILITARY. DURING THE PROCEDURE, METAL PIECES FROM THE BLADE AND/OR BUR ALLEGEDLY FLAKED OFF INTO THE PT'S RIGHT ANKLE. ACCORDING TO THE REP WHO CALLED THIS IN, THE PIECES ARE STILL IN THE PT AND THERE HAS BEEN SEVERE SWELLING. THE SURGERY WAS COMPLETED WITH EXISTING BLADES, HOWEVER, THE BLADES AND BURS THAT ARE IN QUESTION WERE ALLEGEDLY THROWN AWAY BY THE SURGEON.
Additional Manufacturer Narrative
DEVICE NOT RETURNED TO MFR. ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.