PURIST
Received Jul 28, 2023 · Event occurred Mar 23, 2023
Report 3009611746-2023-00001 · MDR key 17415327
Device
Generic name
Table And Attachments - Operating Room- Leg Positioning System
Manufacturer
Jossi AgCatalog number
6813100
Lot number
6813100.0158
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
77 YR · Female
- Bone Fracture(s)
- Bone Fracture(s)
Narrative
Description of Event or Problem
A FEW DAYS AFTER A HIP REPLACEMENT SURGERY THAT WAS PERFORMED ON (B)(6) 2023, A FRACTURE OF THE PATIENT'S MALLEOLUS WAS DETECTED. THE SURGEON EXPRESSED A SUSPICION THAT THE FRACTURE MAY HAVE BEEN CREATED DURING THE HANDLING OF THE PATIENT'S LEG THAT WAS PERFORMED WITH THE HELP OF THE PURIST LEG POSITIONER. IT IS UNCLEAR WHAT ACTUALLY CAUSED THE FRACTURE. A PLASTER CAST HAS BEEN APPLIED TO THE PATIENT. THE PATIENT IS A 77-YEAR-OLD WOMAN WITH NORMAL-SIZED FEET. NO MALFUNCTION OF THE PURIST LEG POSITIONER WAS OBSERVED. THE SURGEON NOTIFIED THE MANUFACTURER ON JULY 5, 2023 OF THIS EVENT.
Additional Manufacturer Narrative
DURING INVESTIGATION, THE FOLLOWING ITEMS HAD BEEN CHECKED : TRAINING OF THE USERS, STATE OF FUNCTIONING OF THE DEVICE, STATE OF HEALTH OF THE PATIENT INCLUDING BONE QUALITY, FOLLOWING THE IFU AND SURGICAL PROCEDURE. NO FAILURES OR DEVIATIONS WERE FOUND . SO, THE CAUSE OF THE BONE FRACTURE IS UNKNOWN AND MAY BE LINKED TO THE BONE QUALITY OF THE PATIENT. THIS CASE SEEMS TO BE AN ISOLATED CASE.