inforMED
MalfunctionLFL

MISONIX ULTRASONIC BONE SCALPEL

Received Feb 17, 2026 · Event occurred Feb 3, 2026

Report MW5183892 · MDR key 24365301

Device

Generic name

Instrument, Ultrasonic Surgical

Manufacturer

Bioventus Llc

Model number

100-92-0000

Patient

3 MO · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING THE SURGICAL PROCEDURE--SAGITTAL STRIP CRANIECTOMY WITH BARREL STAVE OSTEOTOMIES AND CRANIAL VAULT REMODELING, THE MISONIX BONE SCALPEL HAND PIECE (005) BECAME HOT AND UNABLE TO BE USED DURING THE CASE. WAS REMOVED IMMEDIATELY, THE HAND PIECE AND THE MACHINE TAKEN OUT OF SERVICE AND VENDOR INFORMED MACHINE REF # 100-92-0000, SN (B)(6).