inforMED
MalfunctionHTW

NA

Received Sep 26, 2025 · Event occurred Sep 14, 2025

Report 23154103 · MDR key 23154103

Device

Generic name

Bit, Drill

Manufacturer

Zimmer, Inc.

Model number

4806-85-15

Catalog number

00-4806-085-15

Product problems

  • Break

Patient

13 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FROM STAFF: DURING ORTHOPEDIC SURGERY OF RIGHT ELBOW, CST [CERTIFIED SURGICAL TECHNOLOGIST] NOTICED THAT THE SURGEON HAD BROKEN OFF THE TIP OF A ZIMMER DRILL BIT AS IT WAS BEING RETURNED TO HER. CST ALERTED SURGEON, ZIMMER REP, & RN CIRCULATOR IMMEDIATELY AFTER NOTICING. TIP OF DRILL BIT WAS RETAINED IN THE PATIENT'S HARDWARE, AS SEEN ON X-RAY. PER SURGEON, THIS IS NOT OF CLINICAL CONCERN AND WILL NOT HAVE AN EFFECT ON THE PATIENT'S HEALING. FROM OPERATIVE REPORT: OF NOTE A PIECE OF THE 1.5 MM DRILL BIT BROKEN WAS INTRAOSSEOUS. I VISUALIZED THIS ON AP [ANTERIOR POSTERIOR XRAY] AND LATERAL FLUOROSCOPIC IMAGES. I FELT THAT THE HARM WAS MORE THAN THE BENEFITS OF TRYING TO REMOVE THE BROKEN DRILL BIT PIECE WHICH WAS INTRAOSSEOUS. AT THIS POINT I THEN PUT THE ELBOW THROUGH RANGE MOTION, AND IT WAS CONCENTRICALLY REDUCED AND UNDER DYNAMIC EXAM UNDER FLUOROSCOPY IT REMAIN CONCENTRICALLY REDUCED AS WELL. AT THIS POINT GOOD HEMOSTASIS WAS ACHIEVED AND NOTED.