ORTHOLOC 3Di 59250095Recalls & reported problems
Wright Medical Technology, Inc. · Star 20 Driver · Class 1
All models of ORTHOLOC 3Di (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889797022583), received between Oct 29, 2022 and Jan 26, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break3
- Fracture3
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2023Break; Fracture; Break; Fracture
SCREWDRIVER BLADES FROM THE ORTHOLOC 3DI ANKLE FUSION SYSTEM ARE BROKEN AT THE TIP WHEN SCREWING IN THE LOCKING SCREWS. IT WAS NOT KNOWN IF DEBRIS WAS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16247779 ↗MalfunctionJan 26, 2023Break; Fracture; Break; Fracture
SCREWDRIVER BLADES FROM THE ORTHOLOC 3DI ANKLE FUSION SYSTEM ARE BROKEN AT THE TIP WHEN SCREWING IN THE LOCKING SCREWS. IT WAS NOT KNOWN IF DEBRIS WAS LEFT IN THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 16247778 ↗MalfunctionOct 29, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING USE INSERTING A SCREW. THE TIP COULD NOT BE REMOVED FROM SCREW SO THE SURGEON REMOVED AND REPLACED THE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15694410 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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