SUBTALAR MBA IMPLANT 14MM
Received Aug 11, 2011
Report 3004608878-2011-00113 · MDR key 2222539
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE REPORTER STATED THAT THE PATIENT WAS ANESTHETIZED FOR A SURGICAL PROCEDURE TO IMPLANT THE SUBTALAR MBA SYSTEM (INDICATED FOR USE IN TREATMENT OF THE HYPERPRONATED FOOT AND STABILIZATION OF THE SUBTALAR JOINT). THE SURGEON REQUESTED A SIZE 14 MM IMPLANT. THE PRODUCTS AVAILABLE IN THE HOSPITAL INVENTORY HAD AN EXPIRATION DATE OF JUNE 30, 2011. THE SURGERY WAS DONE ON (B)(6) 2011. THE USER FACILITY ELECTED TO REPROCESS THE PRODUCTS IN THE HOSPITAL AUTOCLAVE (WITH BIOLOGICAL INDICATORS) IN ACCORDANCE WITH JOINT COMMISSION PROTOCOLS. THERE HAS BEEN NO ADVERSE OUTCOME FOR THE PATIENT TO DATE. THE PRODUCTS HAD BEEN PART OF THE HOSPITAL'S OWN INVENTORY.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.