BONE DEPTH GAUGE 231200100Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
- 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 00880304533509), received between Jan 25, 2024 and Aug 22, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20035432 ↗MalfunctionAug 20, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE TIP OF DEPTH GAUGE WAS FRACTURED OFF AND WAS MISSING. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20005906 ↗MalfunctionFeb 29, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18807380 ↗MalfunctionJan 25, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18579198 ↗
Other GAUGE, DEPTH devices
- NA 319.006Synthes GmbH · GAUGE, DEPTH899 reports
- NA 03.133.080Synthes GmbH · GAUGE, DEPTH174 reports
- NA 03.010.072Synthes GmbH · GAUGE, DEPTH133 reports
- MULTILOC 03.019.017Synthes GmbH · GAUGE, DEPTH119 reports
- NA 319.01Synthes GmbH · GAUGE, DEPTH113 reports
- NA 319.004Synthes GmbH · GAUGE, DEPTH82 reports
- QUICKSET 2274-60-000Depuy (Ireland) · GAUGE, DEPTH68 reports
- NA 319.09Synthes GmbH · GAUGE, DEPTH65 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.