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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#349 of 1000 · 4,020 reports · 1996–2026

  • BOOK 4,020 reports
  • RANK #349 of 1000
  • DEATH 4 death-typed
  • INJ 1,264 injury-typed
  • MALF 2,665 malfunction
  • SPAN 1996–2026
  • PEAK 2024: 507
  • PHOTO Orthosis

Nearest event-volume peer: Orthosis, Spinal Pedicle Fixation (50 report gap)

Instrument, Manual, Surgical, General Use sits #349 of 1000 among tracked device types with 4,020 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 31.4% corpus 30.4% · above corpus mean (+1.0 pp)
  • MALF 66.3% corpus 64.5% · above corpus mean (+1.8 pp)

Lead product-problem code Break is 57% of coded problems · Lead manufacturer ARTHREX, INC. accounts for 58% of manufacturer-tagged reports · Top event location is 46% 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 4,020 MAUDE reports, ranked #349 of 1000.

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

Event Types

Malfunction 2,665 (66.3%)
Injury 1,264 (31.4%)
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.

2,450 (57.7%)
Other 1,107 (26.1%)
Required Intervention 240 (5.7%)
Hospitalization 206 (4.9%)
R 171 (4.0%)
O 41 (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 1,683
Fracture 208
Detachment Of Device Component 122
Detachment of Device or Device Component 104
Difficult to Remove 83
Physical Resistance/Sticking 75
Entrapment of Device 74
Material Twisted/Bent 68
Material Fragmentation 65
Adverse Event Without Identified Device or Use Problem 62
Component Missing 56
Insufficient Information 56
Dull, Blunt 46
Appropriate Term/Code Not Available 41
Device Or Device Fragments Location Unknown 37
Crack 36
Device Operates Differently Than Expected 34
Corroded 30
Defective Device 28
Device Damaged by Another Device 24

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: 41

Related Entities for Instrument, Manual, Surgical, General Use

Top Manufacturers

ARTHREX, INC. 1,769
SMITH & NEPHEW, INC. 512
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

1,841 (45.8%)
I 1,587 (39.5%)
HOSPITAL 291 (7.2%)
NOT APPLICABLE 173 (4.3%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, Manual, Surgical, General Use, 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 (4,020 here).

Orthosis, Spinal Pedicle Fixation 3,970 Electrode, Ion Specific, Sodium 3,925 Prosthesis 4,144 Catheter, Straight 4,147

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.