PERIOSTEAL ELEVATOR, ROUND, 6MM WIDE
Received Jun 27, 2013 · Event occurred Apr 17, 2012
Report 2520274-2013-03577 · MDR key 3194969
Device
Product problems
- Corroded
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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 HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS NOT YET AVAILABLE.
Additional Manufacturer Narrative
DHR NOT AVAILABLE AS DEVICE IS OLDER THAN 15 YEARS. ACCORDING TO SE_075477 THE DOCUMENTS FOR INSTRUMENTS HAVE TO BE STORED FOR 10 YEARS. EVENT DATE ¿ 4/17/12. AWARE DATE ¿ 4/17/12.
Description of Event or Problem
THE INSTRUMENTS (MOST PERIOSTAL ELEVATORS) STARTED TO OXIDIZE AT THE TRANSITION POINT, FROM THE STEEL PORTION TO THE HANDLE. THE STERILIZATION PROCEDURE AT THE HOSPITAL WAS NOT CHANGED AND IT IS UNCLEAR WHAT CAUSED THIS EVENT.
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).