MalfunctionHXX
PARAGON
Received Dec 15, 2025 · Event occurred Dec 5, 2025
Report MW5180548 · MDR key 23810796
Device
Product problems
- Break
- Difficult to Remove
Patient
NA · Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING THE CASE, A PARAGON SCREWDRIVER WAS BEING USED AND THE TIP OF THE SCREWDRIVER BROKE OFF INSIDE THE SCREW IN THE PATIENT'S RIGHT ANKLE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE TIP HOWEVER THEY WERE UNSUCCESSFUL. DIRECTOR AND ASSISTANT MANAGER WERE NOTIFIED. DR DISCLOSED TO PATIENT'S FAMILY THAT A PIECE WAS LEFT IN AND HE INCLUDED IT IN HIS POST OP NOTE. THE REF NUMBER OF THE SCREWDRIVER IS (B)(4). MIDAS 25-52631.