NA 03.505.044Recalls & reported problems
Synthes GmbH · 1.5MM DIA DRILL BIT W/8MM STOP 15MM LENGTH F/90° SCREWDRIVER · Class 2
- 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 10887587013503), received between May 29, 2025 and May 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionMay 29, 2025Break; Break
IT WAS REPORTED THAT DURING AN ORTHOGNATHIC SURGERY, AT THE TIME OF USING INSTRUMENTAL SCREWDRIVER OF 90 DEGREES IN THE MAXILLA, THE BIT WAS BROKEN IN HALF. SURGERY WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY. THE FRAGMENTS GENERATED WERE REMOVED EASILY WITHOUT REQUIRING ADDITIONAL INTERVENTION. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22103554 ↗
Other DRILL, BONE, POWERED devices
- NA 03.505.004Synthes GmbH · DRILL, BONE, POWERED69 reports
- Nobel Biocare® 37470Nobel Biocare AB · DRILL, BONE, POWERED1 recall0 reports
- MatrixMANDIBLE 03.503.476Synthes GmbH · DRILL, BONE, POWERED26 reports
- NA 310.510Synthes GmbH · DRILL, BONE, POWERED17 reports
- NA 317.82Synthes GmbH · DRILL, BONE, POWERED16 reports
- MatrixMANDIBLE 03.503.479Synthes GmbH · DRILL, BONE, POWERED11 reports
- NA 05.001.120Synthes GmbH · DRILL, BONE, POWERED9 reports
- NA 310.520Synthes GmbH · DRILL, BONE, POWERED9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.