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2026 data FDA MAUDE openFDA FDA Class II

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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 §874.4250 (Ear, Nose, Throat panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Drill, Surgical, Ent Including Handpiece MID-BOOK · MAUDE

#109 of 1000 · 29,783 reports · 1997–2026

  • BOOK 29,783 reports
  • RANK #109 of 1000
  • DEATH 4 death-typed
  • INJ 283 injury-typed
  • MALF 29,457 malfunction
  • SPAN 1997–2026
  • PEAK 2013: 3,231
  • PHOTO Dialysate Concentrate…

Nearest event-volume peer: Dialysate Concentrate For Hemodialysis (Liquid Or Powder) (225 report gap)

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece sits #109 of 1000 among tracked device types with 29,783 MAUDE reports spanning 1997–2026. 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

Drill, Surgical, Ent Including Handpiece carries 98.9% MALFUNCTION-coded reports, 34.1pp 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 1.0% corpus 30.3% · below corpus mean (-29.3 pp)
  • MALF 98.9% corpus 64.8% · above corpus mean (+34.1 pp)

Lead product-problem code Overheating of Device is 46% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 35% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Drill, Surgical, Ent Including Handpiece in the event-volume neighbourhood

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

reports

What this shows Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece carries 29,783 MAUDE reports, ranked #109 of 1000.

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

Event Types

Malfunction 29,457 (98.9%)
Injury 283 (1.0%)
27 (0.1%)
Other 12 (0.0%)
Death 4 (0.0%)

Patient Outcomes

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

29,412 (98.9%)
Other 155 (0.5%)
Required Intervention 126 (0.4%)
Hospitalization 20 (0.1%)
R 9 (0.0%)
Life Threatening 9 (0.0%)
Death 5 (0.0%)
Disability 5 (0.0%)
L 3 (0.0%)
O 3 (0.0%)
Congenital Anomaly 3 (0.0%)
H 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Overheating of Device 12,985
Break 1,559
Device Displays Incorrect Message 1,295
Detachment of Device or Device Component 1,195
Device Remains Activated 1,116
Excessive Heating 982
Device Operates Differently Than Expected 902
Fluid/Blood Leak 899
Noise, Audible 853
Unintended System Motion 821
Temperature Problem 738
Unintended Power Up 737
Vibration 696
Output below Specifications 656
Leak/Splash 613
Hole In Material 463
Device Inoperable 453
Self-Activation or Keying 439
Device Damaged by Another Device 341
Fail-Safe Problem 335

Yearly Trend

97
1997: 2
98
1998: 2
99
1999: 2
00
2000: 2
01
2001: 5
02
2002: 25
03
2003: 62
04
2004: 102
05
2005: 36
06
2006: 74
07
2007: 112
08
2008: 60
09
2009: 249
10
2010: 444
11
2011: 1,068
12
2012: 1,379
13
2013: 3,231
14
2014: 1,975
15
2015: 2,630
16
2016: 1,455
17
2017: 999
18
2018: 1,380
19
2019: 2,515
20
2020: 2,369
21
2021: 2,283
22
2022: 1,574
23
2023: 1,725
24
2024: 1,588
25
2025: 1,494
26
2026: 941

Reports in 2025 (1,494) held close to the prior two-year average of 1,657.

Related Entities for Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Top Manufacturers

STRYKER INSTRUMENTS-KALAMAZOO 10,174
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4,780
DEPUY SYNTHES POWER TOOLS 4,207
DEPUY SYNTHES PRODUCTS LLC 2,962
STRYKER INSTRUMENTS KALAMAZOO 2,766
MEDTRONIC XOMED INC. 2,522
THE ANSPACH EFFORT, INC. 715
MDT POWERED SURGICAL SOLUTIONS 317
SYNTHES GMBH 225
MEDTRONIC XOMED, INC. 141

Event Locations

17,615 (59.1%)
I 11,961 (40.2%)
HOSPITAL 114 (0.4%)
NO INFORMATION 41 (0.1%)
NURSING HOME 39 (0.1%)
AMBULATORY SURGICAL FACILITY 5 (0.0%)
OTHER 5 (0.0%)
OPERATING ROOM 2 (0.0%)
HOME 1 (0.0%)

Compare STRYKER INSTRUMENTS-KALAMAZOO vs STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Drill, Surgical, Ent Including Handpiece: 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 (29,783 here).

Dialysate Concentrate For Hemodialysis 30,008 Reamer 29,419 Wheelchair, Powered 30,542 Bronchoscope 31,113

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Electrode 4 Electrode, Ion Specific, Potassium 4

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

Disclaimer: MAUDE figures for Drill, Surgical, Ent Including Handpiece 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 Drill, Surgical, Ent Including Handpiece; 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.