SYMMETRY MALIS
Received Jun 23, 2020 · Event occurred Feb 21, 2020
Report 3007208013-2020-00014 · MDR key 10185154
Device
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS ABLE TO PROVIDE PICTURES OF THE DAMAGED INSTRUMENT. THE PICTURES PROVIDED CONFIRMED THAT THE MANUFACTURE DATE OF THE PRODUCT WAS JANUARY 2009. THEREFORE, THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY 11 YEARS. THIS IS A DELICATE INSTRUMENT AND CAN BE DAMAGE WHEN EXCESSIVE STRESS IS APPLIED. IT CAN BE DETERMINED THAT TIP BROKE OFF DUE TO A COMBINATION OF EXCESSIVE STRESS AND EXTENSIVE USE OVER 11 YEARS. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR A NEED FOR CORRECTIVE ACTIONS A FOLLOW UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
THE CUSTOMER IS NOT ABLE TO PROVIDE THE LOT NUMBER OR SALES ORDER FROM WHEN IT WAS PURCHASED. AT THIS TIME, THE CUSTOMER IS NOT ABLE TO RETURN DUE TO THEIR REGULATIONS OF RETURNING USED AND SHARP INSTRUMENTS. PICTURES OF THE BREAK AND THE ETCHING HAVE BEEN REQUESTED TO COMPLETE AN EVALUATION. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF THIS PRODUCT SINCE 2012 WITH THREE ADDITIONAL COMPLAINTS RECORDED FOR DAMAGED TIPS. ALL THREE COMPLAINTS WERE TIPS THAT WERE DAMAGED DURING SHIPPING. THERE HAVE BEEN NO OTHER COMPLAINTS OF IT OCCURRING DURING A PROCEDURE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE EVALUATED THE PICTURES PROVIDED BY THE CUSTOMER.
Description of Event or Problem
DURING THE PROCEDURE, THE NERVE HOOK TIP BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS RECOVERED IN THE SUCTION CANISTER. THERE WAS NO PATIENT HARM.