HOEN
Received Oct 8, 2015 · Event occurred Aug 13, 2015
Report 3007208013-2015-00026 · MDR key 5147864
Device
Generic name
Dural Separator
Manufacturer
Symmetry Surgical Inc.Model number
65-1102Catalog number
65-1102
Product problems
- Insufficient Device Problem Information
- Appropriate Device Problem Term/Code Not Available
Patient
43 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
SYMMETRY DID NOT RECEIVE THE BROKEN DEVICE BACK FROM THE HOSPITAL. DEVICE FAILURE WAS DETERMINED TO BE MISUSE OF THE PRODUCT. INSTRUMENT SPECIALIST ON SITE INDICATED: DEVICE IS INTENDED TO SEPARATE THE DURA MATER THAT COATS THE BRAIN AND THE SPINAL CORD, DEVICE SHOULD NOT BE STRUCK.
Description of Event or Problem
DURING A POSTERIOR LUMBAR DISCECTOMY THE TIP OF THE HOEN DURAL SEPARATOR BROKE OFF INSIDE THE PATIENT WHEN STRUCK WITH A MALLET BY THE SURGEON. A C-ARM X-RAY WAS BROUGHT IN TO LOCATE THE BROKEN TIP THAT WAS IN THE PATIENT. THE BROKEN PIECE WAS RECOVERED WITHOUT HARM TO THE PATIENT. THE DEVICE WAS DISPOSED OF.
Remedial action
- Other