Cannulated Compression Headless Screw 03.333.101Recalls & reported problems
Tyber Medical, LLC · 2.0MM CANN DRILL BIT QC/ 145MM · Class 1
All models of Cannulated Compression Headless Screw (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00819917026566), received between Aug 14, 2025 and Aug 14, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2025Fracture; Fracture
IT WAS REPORTED THAT ON (B)(6) 2025 WHILE DRILLING THROUGH THE 1ST MET, RESIDENT DOCTOR MENTIONED THAT THERE WASN'T FEELING LIKE THERE WAS MUCH POWER OR ANY ADVANCEMENTS WITH THE DRILL BIT. THE SURGEON ASSUMED IT WAS DUE TO THE NATURE OF THE PATIENT'S HARDER THAN AVERAGE BONE AS THE SURGEON HAD ALREADY GONE THROUGH 3 SAW BLADES PRIOR TO THIS INCIDENT. UPON PULLING THE DRILL BIT OUT OF THE TISSUE SLEEVE, THE RESIDENT NOTICED THE DRILL BIT HAD SNAPPED. UPON FLUORO, IT WAS DISCOVERED THAT THE TIP OF THE DRILL BIT HAD SNAPPED INTO ONE LARGE PIECE, AND 2 SMALLER PIECES WHILE ALSO DAMAGING THE DRILL SLEEVE WHEN PULLING OUT. THE SURGEON WAS ABLE TO REMOVE THE LARGE PIECE OF THE DRILL BIT BUT WAS UNABLE TO RECOVER THE 2 SMALLER FRAGMENTS THAT WERE STUCK WITHIN THE BONE/OSTEOTOMY SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22811861 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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