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2026 data FDA MAUDE openFDA FDA Class I

Instrument, Manual, Surgical, General Use

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 §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Instrument, Manual, Surgical, General Use LIGHT-BOOK · MAUDE

#351 of 1000 · 4,143 reports · 1996–2026

  • BOOK 4,143 reports
  • RANK #351 of 1000
  • DEATH 4 death-typed
  • INJ 1,282 injury-typed
  • MALF 2,770 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 507
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented (27 report gap)

Instrument, Manual, Surgical, General Use sits #351 of 1000 among tracked device types with 4,143 MAUDE reports spanning 1996–2026. 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

Instrument, Manual, Surgical, General Use carries 66.9% MALFUNCTION-coded reports, 2.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 30.9% corpus 30.3% · above corpus mean (+0.7 pp)
  • MALF 66.9% corpus 64.8% · above corpus mean (+2.0 pp)

Lead product-problem code Break is 54% of coded problems · Lead manufacturer ARTHREX, INC. accounts for 59% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Instrument, Manual, Surgical, General Use in the event-volume neighbourhood

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

reports

What this shows Instrument, Manual, Surgical, General Use carries 4,143 MAUDE reports, ranked #351 of 1000.

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

Event Types

Malfunction 2,770 (66.9%)
Injury 1,282 (30.9%)
Other 78 (1.9%)
9 (0.2%)
Death 4 (0.1%)

Patient Outcomes

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

2,544 (58.4%)
Other 1,118 (25.7%)
Required Intervention 246 (5.6%)
Hospitalization 206 (4.7%)
R 171 (3.9%)
O 42 (1.0%)
S 11 (0.3%)
Disability 8 (0.2%)
L 3 (0.1%)
Death 3 (0.1%)
Life Threatening 3 (0.1%)
H 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Break 2,274
Detachment Of Device Component 317
Fracture 267
Difficult to Remove 184
Replace 136
Detachment of Device or Device Component 130
Entrapment of Device 94
Material Fragmentation 86
Physical Resistance/Sticking 77
Material Twisted/Bent 71
Insufficient Device Problem Information 70
Tip breakage 69
Device Or Device Fragments Location Unknown 66
Component Missing 64
Adverse Event Without Identified Device or Use Problem 63
Device, or device fragments remain in patient 61
Dull, Blunt 61
Material Separation 51
Device Operates Differently Than Expected 50
Component Falling 46

Yearly Trend

96
1996: 1
97
1997: 5
98
1998: 13
99
1999: 112
00
2000: 34
01
2001: 41
02
2002: 27
03
2003: 62
04
2004: 44
05
2005: 60
06
2006: 40
07
2007: 25
08
2008: 50
09
2009: 131
10
2010: 49
11
2011: 52
12
2012: 53
13
2013: 74
14
2014: 66
15
2015: 161
16
2016: 317
17
2017: 187
18
2018: 400
19
2019: 281
20
2020: 245
21
2021: 227
22
2022: 182
23
2023: 209
24
2024: 507
25
2025: 324
26
2026: 164

Reports in 2025 (324) held close to the prior two-year average of 358.

Related Entities for Instrument, Manual, Surgical, General Use

Top Manufacturers

ARTHREX, INC. 1,873
SMITH & NEPHEW, INC. 514
ARTHREX, INC. 243
BIOMET ORTHOPEDICS 190
ETHICON ENDO-SURGERY, LLC. 86
ZIMMER BIOMET, INC. 72
COVIDIEN 71
ARTHREX INC. 59
ETHICON ENDO-SURGERY, INC. (CINCINNATI) 56

Event Locations

1,965 (47.4%)
I 1,586 (38.3%)
HOSPITAL 291 (7.0%)
NOT APPLICABLE 173 (4.2%)
NO INFORMATION 82 (2.0%)
OTHER 25 (0.6%)
AMBULATORY SURGICAL FACILITY 16 (0.4%)
UNKNOWN 3 (0.1%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare ARTHREX, INC. vs SMITH & NEPHEW, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument, Manual, Surgical, General Use: 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 (4,143 here).

Prosthesis 4,170 Stretcher, Wheeled, Powered 4,226 Catheter, Straight 4,229 Electrode, Ion Specific, Sodium 3,993

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 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Instrument, Manual, Surgical, General Use 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 Instrument, Manual, Surgical, General Use; 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.