SYMMETRY
Received May 26, 2022 · Event occurred Mar 9, 2022
Report 3007208013-2022-00017 · MDR key 14516520
Device
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
VOLUNTARY REPORT MW5108659 WAS RECEIVED IN THE MAIL ON 05/03/2022. NO FURTHER INFORMATION HAS BEEN RECEIVED YET. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE WE HAVE MORE INFORMATION.
Description of Event or Problem
THE CUSTOMER ALLEGED THAT UPON STARTING THE CRANIOTOMY, THE DEVICE BROKE. ALL PIECES WERE ACCOUNTED FOR.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION WAS PROVIDED ON 6/9/2022: - THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DESTROYED AND NO PICTURES WERE TAKEN. - A PIECE FELL INTO THE PATIENT, IT WAS AT THE BEGINNING OF THE CASE. THE PIECES WERE RETRIEVED WITH NO HARM TO THE PATIENT OR IMAGING REQUIRED. WITHOUT THE RETURN OF THE DEVICE OR PICTURES, IT CANNOT BE CONFIRMED WHERE THE DEVICE BROKE. ADDITIONALLY, ROOT CAUSE CANNOT BE DETERMINED WITHOUT ADDITIONAL INFORMATION. THIS IS THE FIRST COMPLAINT RECORDED WITH (B)(4). BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.