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2026 data FDA MAUDE openFDA FDA Class I

Handpiece, Direct Drive, Ac-Powered

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §872.4200 (Dental panel).

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FDA MAUDE casebook

openFDA event book Handpiece, Direct Drive, Ac-Powered LIGHT-BOOK · MAUDE

#765 of 1000 · 736 reports · 1994–2026

  • BOOK 736 reports
  • RANK #765 of 1000
  • DEATH 0 death-typed
  • INJ 54 injury-typed
  • MALF 677 malfunction
  • SPAN 1994–2026
  • PEAK 2014: 102
  • PHOTO Gastrointestinal Tube…

Nearest event-volume peer: Gastrointestinal Tubes With Enteral Specific Connectors (4 report gap)

Handpiece, Direct Drive, Ac-Powered sits #765 of 1000 among tracked device types with 736 MAUDE reports spanning 1994–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Handpiece, Direct Drive, Ac-Powered carries 92.0% MALFUNCTION-coded reports, 27.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 7.3% corpus 30.3% · below corpus mean (-23.0 pp)
  • MALF 92.0% corpus 64.8% · above corpus mean (+27.2 pp)

Lead product-problem code Overheating of Device is 36% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 100% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Handpiece, Direct Drive, Ac-Powered in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Handpiece, Direct Drive, Ac-Powered carries 736 MAUDE reports, ranked #765 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 677 (92.0%)
Injury 54 (7.3%)
Other 3 (0.4%)
2 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

675 (91.5%)
Other 29 (3.9%)
Required Intervention 28 (3.8%)
R 2 (0.3%)
Hospitalization 2 (0.3%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Overheating of Device 331
Detachment of Device or Device Component 149
Mechanical Problem 124
Retraction Problem 41
Device Operates Differently Than Expected 35
Defective Device 32
Unintended Movement 24
Self-Activation or Keying 23
Dent in Material 22
Break 18
Therapeutic or Diagnostic Output Failure 18
Computer Operating System Problem 17
Output Problem 16
Physical Resistance/Sticking 15
Device Handling Problem 14
Temperature Problem 10
Inappropriate/Inadequate Shock/Stimulation 9
Failure to Calibrate 8
Material Separation 8
Unintended Electrical Shock 7

Yearly Trend

94
1994: 2
95
1995: 1
98
1998: 1
02
2002: 2
03
2003: 2
05
2005: 5
06
2006: 6
07
2007: 9
08
2008: 10
09
2009: 11
10
2010: 20
11
2011: 6
12
2012: 27
13
2013: 45
14
2014: 102
15
2015: 68
16
2016: 66
17
2017: 10
18
2018: 49
19
2019: 56
20
2020: 67
21
2021: 79
22
2022: 37
23
2023: 14
24
2024: 19
25
2025: 9
26
2026: 13

Reports fell to 9 in 2025, down from an average of 17 in the two years before.

Related Entities for Handpiece, Direct Drive, Ac-Powered

Top Manufacturers

SYNTHES GMBH 12

Event Locations

363 (49.3%)
I 323 (43.9%)
OTHER 37 (5.0%)
NO INFORMATION 5 (0.7%)
HOSPITAL 2 (0.3%)
OUTPATIENT TREATMENT FACILITY 2 (0.3%)
HOME 1 (0.1%)
INVALID DATA 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Handpiece, Direct Drive, Ac-Powered carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (736 here).

Gastrointestinal Tubes With Enteral Specifi… 732 Pacemaker Lead Adaptor 741 Carboxymethylcellulose Sodium Or Polyvinyl… 729 Implanted Brain Stimulator For Epilepsy 746

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Handpiece, Direct Drive, Ac-Powered are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Handpiece, Direct Drive, Ac-Powered; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.