FILTER RETENTION PLATE
Received Aug 19, 2020 · Event occurred Jan 17, 2020
Report 9610612-2020-00390 · MDR key 10426033
Device
Product problems
- Defective Device
- Defective Device
Patient
Not reported
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
WITHOUT THE PRODUCT ITSELF AND THE PARTICLES OBSERVED, A TRACING BACK OF THE MATERIAL TO THE RETENTION PLATE IS NOT POSSIBLE. HOWEVER, IT IS ALSO NOT POSSIBLE TO FULLY EXCLUDE THAT THE PARTICLE'S ORIGIN IS THE RETENTION PLATE. WITHOUT THE PARTICLES AND THE RETENTION PLATE IN QUESTION AVAILABLE FOR FURTHER INVESTIGATION, THE ORIGIN OF THE PARTICLES CANNOT BE SECURELY DETERMINED. BESIDES THE RETENTION PLATE AS SUBJECT TO THIS COMPLAINT, COMPONENTS FROM THE SURGERY SET WITH SYNTHETIC MATERIAL CAN ALSO BE A FURTHER POTENTIAL ORIGIN FOR THOSE PARTICLES. AFTER THE 8 D REPORT A CAPA IS NOT NECESSARY.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FILTER RETENTION PLATE. IT WAS REPORTED THAT IN THE CENTRAL STERILIZATION REPROCESSING DEPARTMENT, THE TECHNICIANS SAW "FRICTION" AND BLACK SPECKS ON THE BLACK CENTER OF THE RETENTION PLATES. THERE WAS A SURGERY DELAY. ANOTHER SET OF ORTHOPEDIC TRAYS WERE USED INSTEAD. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE: (B)(4).