MalfunctionHXI
MONSTER SCREW SYSTEM
Received Jul 17, 2026 · Event occurred Jul 9, 2026
Report 25853791 · MDR key 25853791
Device
Generic name
Passer, Wire, Orthopedic
Manufacturer
Paragon 28, Inc.Model number
P99-192-1215Catalog number
P99-192-1215
Lot number
UNKNOWN
Patient
66 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SCRUB TECH NOTIFIED PHYSICIAN THAT THE TIP OF THE K-WIRE WAS BENT PRIOR TO MD INSERTION. MD PROCEEDED AND TIP OF K-WIRE BROKE OFF IN TIBIAL BONE.