2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#108 of 1000 · 29,022 reports · 1997–2026

  • BOOK 29,022 reports
  • RANK #108 of 1000
  • DEATH 4 death-typed
  • INJ 279 injury-typed
  • MALF 28,700 malfunction
  • SPAN 1997–2026
  • PEAK 2013: 3,231
  • PHOTO Reamer

Nearest event-volume peer: Reamer (49 report gap)

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece sits #108 of 1000 among tracked device types with 29,022 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.0% corpus 30.4% · below corpus mean (-29.5 pp)
  • MALF 98.9% corpus 64.5% · above corpus mean (+34.4 pp)

Lead product-problem code Overheating of Device is 50% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 36% of manufacturer-tagged reports · Top event location is 58% 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 29,022 MAUDE reports, ranked #108 of 1000.

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

Event Types

Malfunction 28,700 (98.9%)
Injury 279 (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.

28,677 (98.8%)
Other 151 (0.5%)
Required Intervention 125 (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 9,335
Detachment of Device or Device Component 1,032
Excessive Heating 952
Device Remains Activated 873
Noise, Audible 652
Break 631
Fluid/Blood Leak 628
Output below Specifications 620
Vibration 602
Unintended System Motion 580
Leak/Splash 383
Unintended Power Up 365
Device Damaged by Another Device 329
Fail-Safe Problem 328
Fail-Safe Did Not Operate 268
Complete Loss of Power 258
Device Displays Incorrect Message 215
Fracture 202
Mechanical Jam 198
Flaked 184

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: 180

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

Event Locations

16,856 (58.1%)
I 11,961 (41.2%)
HOSPITAL 112 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Drill, Surgical, Ent Including Handpiece, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (29,022 here).

Similar death-typed counts

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

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.