2026 data FDA MAUDE openFDA FDA Class II

Driver, Wire, And Bone Drill, Manual

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 II (moderate risk, special controls required), regulated under 21 CFR §872.4120 (Dental panel).

FDA MAUDE casebook

openFDA event book Driver, Wire, And Bone Drill, Manual LIGHT-BOOK · MAUDE

#379 of 1000 · 3,399 reports · 1992–2026

  • BOOK 3,399 reports
  • RANK #379 of 1000
  • DEATH 1 death-typed
  • INJ 113 injury-typed
  • MALF 3,280 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 809
  • PHOTO Adaptor, Hygiene

Nearest event-volume peer: Adaptor, Hygiene (27 report gap)

Driver, Wire, And Bone Drill, Manual sits #379 of 1000 among tracked device types with 3,399 MAUDE reports spanning 1992–2026. 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

Driver, Wire, And Bone Drill, Manual carries 96.5% MALFUNCTION-coded reports, 31.7pp 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 3.3% corpus 30.3% · below corpus mean (-27.0 pp)
  • MALF 96.5% corpus 64.8% · above corpus mean (+31.7 pp)

Lead product-problem code Overheating of Device is 73% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 55% of manufacturer-tagged reports · Top event location is 97% of location-tagged rows .

Driver, Wire, And Bone Drill, Manual in the event-volume neighbourhood

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

reports

What this shows Driver, Wire, And Bone Drill, Manual carries 3,399 MAUDE reports, ranked #379 of 1000.

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

Event Types

Malfunction 3,280 (96.5%)
Injury 113 (3.3%)
3 (0.1%)
Other 2 (0.1%)
Death 1 (0.0%)

Patient Outcomes

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

3,278 (96.4%)
Other 76 (2.2%)
Required Intervention 37 (1.1%)
Hospitalization 4 (0.1%)
R 2 (0.1%)
Death 2 (0.1%)
O 1 (0.0%)

Top Product Problems

Overheating of Device 2,442
Device Displays Incorrect Message 171
Temperature Problem 168
Smoking 85
Fluid/Blood Leak 68
Break 66
Self-Activation or Keying 56
Unintended System Motion 47
Device Remains Activated 45
Leak/Splash 33
Unintended Power Up 33
Insufficient Device Problem Information 27
Device Operates Differently Than Expected 25
Adverse Event Without Identified Device or Use Problem 24
Melted 18
Unintended Movement 16
Detachment Of Device Component 13
Component Falling 12
Failure to Shut Off 9
Patient-Device Incompatibility 9

Yearly Trend

92
1992: 2
96
1996: 1
05
2005: 1
08
2008: 10
09
2009: 142
10
2010: 517
11
2011: 578
12
2012: 621
13
2013: 809
14
2014: 539
15
2015: 18
16
2016: 16
17
2017: 9
18
2018: 8
19
2019: 4
20
2020: 17
21
2021: 22
22
2022: 23
23
2023: 22
24
2024: 13
25
2025: 14
26
2026: 13

Reports in 2025 (14) held close to the prior two-year average of 18.

Related Entities for Driver, Wire, And Bone Drill, Manual

Event Locations

3,299 (97.1%)
I 85 (2.5%)
HOSPITAL 9 (0.3%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
NO INFORMATION 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)

Compare STRYKER INSTRUMENTS KALAMAZOO vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Driver, Wire, And Bone Drill, Manual: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (3,399 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Driver, Wire, And Bone Drill, Manual 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 Driver, Wire, And Bone Drill, Manual; 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.