PANALOK LOOP ANCHOR
Received Oct 6, 2005 · Event occurred Aug 4, 2005
Report 1221934-2005-00175 · MDR key 642928
Device
Generic name
Soft Tissue Fixation Device
Manufacturer
Depuy MitekModel number
210700Catalog number
210700
Lot number
125061
Product problems
- Tip breakage
Patient
UNKNOWN
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
CO'S AFFILIATE IS REPORTING THAT DURING A PROCEDURE THE DISTAL TIP OF THE INSERTER DEVICE BROKE OFF INTO THE PT'S BODY AND REMAINS THERE IN. THE SURGEON HAS NO INTENTIONS OF REVISITING THE OP SITE TO REMOVE THE FRAGMENT AS HE STATES THAT THE FRAGMENT IS FULLY INCAPSULATED IN BONE AND WILL NOT MIGRATE. THE CASE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PT.
Description of Event or Problem
OUR AFFILIATE IS REPORTING THAT DURING A PROCEDURE THE DISTAL TIP OF THE INSERTER DEVICE BROKE OFF INTO THE PATIENT'S BODY AND REMAINS THERE IN. THE SURGEON HAS NO INTENTIONS OF REVISITING THE OP. SITE TO REMOVE THE FRAGMENT AS HE STATES THAT THE FRAGMENT IS FULLY INCAPSULED IN BONE AND WILL NOT MIGRATE. THE CASE WA CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR HARM TO THE PATIENT.