PERIOST-ELEV CURV-SHAFT ROUND EDG W/14 L
Received Jun 20, 2013
Report 2520274-2013-03625 · MDR key 3180871
Device
Product problems
- Corroded
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THERE WAS THE START OF OXIDATION AT THE TRANSITION FROM THE STEEL PART TO THE HANDLE.THIS IS 1 OF 1 REPORT FOR THIS COMPLAINT (B)(4).
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. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE INVESTIGATION HAS SHOWN THAT THIS IS A VERY OLD INSTRUMENT, MORE THAN 10 YEARS OLD. THE VISUAL INSPECTION REVEALED THE HANDLE IS MADE FROM CANEVASIT AND IS PARTIALLY WORN OUT AND THE SHAFT PRESENTS DISCOLORATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND AND WE CONCLUDE THAT HIGH TEMPERATURE CYCLES DURING REPEATED STERILIZATION PROCESSES HAVE LED TO THIS OCCURRENCE. THIS COMPLAINT HAS BEEN DETERMINED TO BE INVALID. (B)(6).
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. DHR NOT AVAILABLE AS DEVICE IS OLDER THAN 15 YEARS.