PERIOSTEAL ELEVATOR, ROUND, 6MM WIDE

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. 510K#: 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 (B)(4) 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 IS UNKNOWN THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED.

Description of Event or Problem

THERE WAS THE START OF OXIDATION AT THE TRANSITION FROM THE STEEL PART TO THE HANDLE. THIS IS 3 OF 3 REPORTS FOR COMPLAINT (B)(4).