Screw driver angled 90° 30014000Recalls & reported problems
W & H Dentalwerk Bürmoos GmbH · Surgical Handpiece · Class 2
Data updated Oct 18, 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 J021300140001), received between Oct 31, 2017 and Oct 31, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Mechanical Jam1
- Smoking1
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.
MalfunctionOct 31, 2017Smoking; Improper or Incorrect Procedure or Method; Mechanical Jam
EVENT DESCRIPTION BY INITIAL REPORTER (B)(4): IT WAS REPORTED BY A COMPANY REPRESENTATIVE THAT DURING A BSSO PROCEDURE, THE RIGHT ANGLE SCREWDRIVER BECAME JAMMED AND STARTED SMOKING. THE DEVICE WAS USED AT A SPEED OF 50,000 RPM'S DESPITE THE FACT THAT THE IFU STATES (AND THE RAS ITSELF IS MARKED WITH) THE INFORMATION TO USE AT A MAXIMUM MOTOR SPEED OF 10,000 RPM'S. THERE WERE NO ADVERSE EVENTS REPORTED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY WITH A BACK UP DRILL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 6989655 ↗
Other Handpiece, Rotary Bone Cutting devices
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- Surgical Straight Handpiece SGS-E2SNakanishi Inc. · Handpiece, Rotary Bone Cutting8 reports
- OsteoMed 450-0034Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING6 reports
- S-12 surgical handpiece 1:2 30061000W & H Dentalwerk Bürmoos GmbH · Handpiece, Rotary Bone Cutting3 reports
- OsteoMed 450-0390Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- OsteoMed 450-0084Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- OsteoMed 450-0021-00Osteomed LLC · HANDPIECE, ROTARY BONE CUTTING3 reports
- S-11 surgical handpiece 1:1 30056000W & H Dentalwerk Bürmoos GmbH · Handpiece, Rotary Bone Cutting2 reports
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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