INSTRUMENT 2107-3325Recalls & reported problems
Howmedica Osteonics Corp. · DRILL BIT · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327212358), received between Dec 10, 2018 and Dec 2, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture3
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2021Fracture; Fracture
THE FOLLOWING WAS REPORTED: DURING THE CASE, FLEX DRILL GUIDE AND DRILL WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12917842 ↗MalfunctionSep 3, 2021Break
STRYKER DRILL BIT #21073325 BROKE INTRA-OPERATIVELY, ALL SURGICAL TEAM MEMBERS AWARE OF BREAKAGE. TWO PIECES RETRIEVED IMMEDIATELY.
Patient problems: Insufficient Information
MAUDE report 12421073 ↗MalfunctionApr 27, 2021Fracture; Fracture
IT WAS REPORTED THAT: IN THE CASE, THE ACETABULUM SCREW BROKEN DURING SCREWING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11730573 ↗MalfunctionDec 10, 2018Break; Fracture; Break; Fracture
IT WAS REPORTED THROUGH MEDWATCH (MW5080983) "DRILL BIT BROKE OFF INTO ACETABULUM ATTEMPTED TO RETRIEVE"
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8147525 ↗
Other Prosthesis, hip, hemi-, femoral, metal devices
- UHR UH1-48-28Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal2 recalls3 reports
- "UNITED" USTAR II Knee System 2515-3213United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3115United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- STAGEONE 431207Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal2 recalls0 reports
- "UNITED" USTAR II Knee System 2515-3111United Orthopedic Corp. · Prosthesis, Hip, Hemi-, Femoral, Metal2 recalls0 reports
- ACTIS 101011050Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal73 reports
- UHR UH1-46-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
- UHR UH1-45-26Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal1 recall11 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.