PERIOST-ELEV STRAIGHT SHAFT ROUND EDG W/
Received Jun 27, 2013
Report 8030965-2013-03704 · MDR key 3195002
Device
Product problems
- Corroded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THERE WAS THE START OF OXIDATION AT THE TRANSITION FROM THE STEEL PART TO THE HANDLE. THIS IS 2 OF 3 REPORTS FOR 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION HAS SHOWN THAT IT CONCERNS VERY OLD INSTRUMENTS, WHICH ARE MORE THAN 10 YEARS OLD. THE HANDLES MADE FROM CANVAS ARE PARTIALLY WORN OUT AND THE SHAFTS PRESENT DISCOLORATIONS. NO MANUFACTURING RELATED ISSUES WERE FOUND AND IT IS CONCLUDED THAT HIGH TEMPERATURE CYCLES DURING REPEATED STERILIZATION PROCESSES HAVE LED TO THIS OCCURRENCE. THE LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.
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. CORRECT MANUFACTURING DATE FROM 04/18/2012 TO 08/01/1990.