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2026 data FDA MAUDE openFDA FDA Class I

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

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 §878.4820 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Instrument LIGHT-BOOK · MAUDE

#644 of 1000 · 1,087 reports · 1996–2026

  • BOOK 1,087 reports
  • RANK #644 of 1000
  • DEATH 0 death-typed
  • INJ 41 injury-typed
  • MALF 1,033 malfunction
  • SPAN 1996–2026
  • PEAK 2013: 411
  • PHOTO Automated Urinalysis…

Nearest event-volume peer: Automated Urinalysis System (1 report gap)

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment sits #644 of 1000 among tracked device types with 1,087 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 carries 95.0% MALFUNCTION-coded reports, 30.2pp 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 3.8% corpus 30.3% · below corpus mean (-26.5 pp)
  • MALF 95.0% corpus 64.8% · above corpus mean (+30.2 pp)

Lead product-problem code Break is 21% of coded problems · Lead manufacturer THE ANSPACH EFFORT, INC. accounts for 42% of manufacturer-tagged reports · Top event location is 84% of location-tagged rows .

Instrument in the event-volume neighbourhood

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

reports

What this shows Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment carries 1,087 MAUDE reports, ranked #644 of 1000.

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

Event Types

Malfunction 1,033 (95.0%)
Injury 41 (3.8%)
Other 10 (0.9%)
3 (0.3%)

Patient Outcomes

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

1,007 (92.0%)
Other 38 (3.5%)
Required Intervention 28 (2.6%)
Hospitalization 9 (0.8%)
R 6 (0.5%)
O 1 (0.1%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Break 189
Device Operates Differently Than Expected 80
Air Leak 53
Other (for use when an appropriate device code cannot be identified) 51
Leak/Splash 50
Fluid/Blood Leak 42
Sticking 40
Material Discolored 38
Residue After Decontamination 38
Device Contamination with Chemical or Other Material 37
Loose 37
Overheating of Device 36
Hole In Material 34
Device Inoperable 31
Material Rupture 31
Burst Container or Vessel 30
Fracture 28
Noise, Audible 27
Failure to Cut 25
Detachment Of Device Component 24

Yearly Trend

96
1996: 1
99
1999: 3
00
2000: 1
02
2002: 3
03
2003: 53
04
2004: 137
05
2005: 34
06
2006: 31
07
2007: 111
08
2008: 13
09
2009: 14
10
2010: 11
11
2011: 3
12
2012: 27
13
2013: 411
14
2014: 18
15
2015: 20
16
2016: 27
17
2017: 24
18
2018: 13
19
2019: 5
20
2020: 13
21
2021: 27
22
2022: 35
23
2023: 39
24
2024: 7
25
2025: 4
26
2026: 2

Reports fell to 4 in 2025, down from an average of 23 in the two years before.

Related Entities for Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Top Manufacturers

THE ANSPACH EFFORT, INC. 322
DEPUY SYNTHES POWER TOOLS 290
SYNTHES GMBH 114
DEPUY SYNTHES PRODUCTS LLC 18
SYNTHES OBERDORF 18

Event Locations

911 (83.8%)
I 104 (9.6%)
NURSING HOME 48 (4.4%)
HOSPITAL 16 (1.5%)
NO INFORMATION 6 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
INVALID DATA 1 (0.1%)

Compare THE ANSPACH EFFORT, INC. vs DEPUY SYNTHES POWER TOOLS →

Nationwide devices with a comparable report-volume footprint

Instrument carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,087 here).

Automated Urinalysis System 1,086 Growing Rod System- Magnetic Actuation 1,094 Introducer, Syringe Needle 1,079 Hemostatic Device For Endoscopic Gastrointe… 1,077

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Instrument 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; 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.