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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Instrument LIGHT-BOOK · MAUDE

#636 of 1000 · 1,086 reports · 1996–2026

  • BOOK 1,086 reports
  • RANK #636 of 1000
  • DEATH 0 death-typed
  • INJ 41 injury-typed
  • MALF 1,032 malfunction
  • SPAN 1996–2026
  • PEAK 2013: 411
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Suction, Patient Care (5 report gap)

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment sits #636 of 1000 among tracked device types with 1,086 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.8% corpus 30.4% · below corpus mean (-26.7 pp)
  • MALF 95.0% corpus 64.5% · above corpus mean (+30.5 pp)

Lead product-problem code Break is 39% 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 1,086 MAUDE reports, ranked #636 of 1000.

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

Event Types

Malfunction 1,032 (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.

1,006 (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 84
Failure to Cut 25
Entrapment of Device 18
Material Rupture 18
Air Leak 14
Leak/Splash 10
Overheating of Device 9
Burst Container or Vessel 5
Device-Device Incompatibility 5
Device Inoperable 4
Excessive Heating 3
Fracture 3
Noise, Audible 3
Device Operates Differently Than Expected 2
Material Deformation 2
Output below Specifications 2
Unintended Movement 2
Use of Device Problem 2
Vibration 2
Adverse Event Without Identified Device or Use Problem 1

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: 1

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

Top Manufacturers

THE ANSPACH EFFORT, INC. 322
DEPUY SYNTHES POWER TOOLS 290
SYNTHES GMBH 113
DEPUY SYNTHES PRODUCTS LLC 18
SYNTHES OBERDORF 18

Event Locations

910 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, 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 (1,086 here).

Apparatus, Suction, Patient Care 1,081 Automated Urinalysis System 1,080 Light Adjustable Lens And Light Delivery De… 1,092 Prosthesis, Hip, Hemi-, Femoral, Metal Ball 1,092

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.