PERIOSTEAL ELEVATOR 13MM CURVED BLADE-STRAIGHT EDGE
Received Apr 3, 2013
Report 8030965-2013-10699 · MDR key 3032236
Device
Manufacturer
Synthes (usa)Catalog number
399.33
Product problems
- Crack
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TWO PERIOSTEAL ELEVATORS WERE FOUND WITH THEIR HANDLES CRACKED AND LEACHING A BROWN COLOR. THEY CANNOT BE USED FOR SURGERY. THIS IS REPORT 1 OF 2 FOR THIS 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 LOT NUMBER PROVIDED COULD NOT BE VERIFIED; THEREFORE, FURTHER INVESTIGATION CANNOT BE PERFORMED. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.
Description of Event or Problem
THIS IS REPORT 1 OF 2 FOR THIS COMPLAINT (B)(4).
Additional Manufacturer Narrative
ADDITIONAL 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 MANUFACTURING EVALUATION SHOWED THAT THE HANDLES ARE CRACKED. THE ELEVATOR CORRESPONDS TO DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE. THE EXACT AGE IS NOT POSSIBLE TO DETERMINE BUT IT APPEARS TO BE VERY OLD. IT IS CONCLUDED THAT THIS COMPLAINT IS INVALID FROM A MANUFACTURING STANDPOINT.