inforMED
MalfunctionHTW

OXF MP 04MM DRILL

Received Dec 3, 2025 · Event occurred Nov 5, 2025

Report 3002806535-2025-00557 · MDR key 23704853

Device

Generic name

Bit, Drill

Manufacturer

Biomet Uk Ltd.

Catalog number

32-423228

Lot number

Z19H2103

Product problems

  • Fracture
  • Fracture

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRILL BIT BROKE FOLLOWING DRILLING. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED. THE BROKEN TIP BRIEFLY REMAINED WITHIN THE BONE BUT WAS COMPLETELY REMOVED WITHOUT ISSUE. THERE WAS NO HEALTH IMPACT TO EITHER THE PATIENT OR THE OPERATOR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.