PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE
Received Mar 20, 2013
Report 8030965-2013-10553 · MDR key 3013481
Device
Product problems
- Corroded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).
Description of Event or Problem
ACCOUNT COMPLAINED TO THE SALES CONSULTANT THAT THE INSTRUMENTS ARE RUSTING AROUND THE ETCH. THIS IS 6 OF 6 REPORTS FOR THE SAME EVENT.
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE HISTORY RECORD WAS NOT AVAILABLE AS INSTRUMENT IS NEARLY 10 YEARS OLD. THE MANUFACTURING VISUAL EVALUATION NOTED THAT THE WHOLE INSTRUMENT IS DISCOLORED. THE RETRACTOR CORRESPONDS TO THE DRAWING AND PROCESSES AT THE TIME OF MANUFACTURE. THE RETRACTOR IS APPROXIMATELY; 10 YEARS OLD AND IT SEEMED AS IT WAS NOT CLEANED PROPERLY.
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4). (B)(4). PLACEHOLDER.