2026 data FDA MAUDE openFDA FDA Class I

Instrument, Surgical, Orthopedic, Dc-Powered Motor And 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).

FDA MAUDE casebook

openFDA event book Instrument LIGHT-BOOK · MAUDE

#421 of 1000 · 2,859 reports · 1997–2026

  • BOOK 2,859 reports
  • RANK #421 of 1000
  • DEATH 2 death-typed
  • INJ 75 injury-typed
  • MALF 2,780 malfunction
  • SPAN 1997–2026
  • PEAK 2011: 1,080
  • PHOTO Pin, Fixation, Smooth

Nearest event-volume peer: Pin, Fixation, Smooth (9 report gap)

Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment sits #421 of 1000 among tracked device types with 2,859 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 →

Malfunction reports run above the device-type norm

Instrument carries 97.2% MALFUNCTION-coded reports, 32.4pp 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 2.6% corpus 30.3% · below corpus mean (-27.7 pp)
  • MALF 97.2% corpus 64.8% · above corpus mean (+32.4 pp)

Lead product-problem code Fluid/Blood Leak is 14% of coded problems · Lead manufacturer STRYKER INSTRUMENTS KALAMAZOO accounts for 85% of manufacturer-tagged reports · Top event location is 98% 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, Dc-Powered Motor And Accessory/Attachment carries 2,859 MAUDE reports, ranked #421 of 1000.

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

Event Types

Malfunction 2,780 (97.2%)
Injury 75 (2.6%)
Death 2 (0.1%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

2,787 (97.5%)
Required Intervention 50 (1.7%)
Other 20 (0.7%)
Hospitalization 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 360
Self-Activation or Keying 223
Sticking 211
Device Slipped 203
Break 201
Overheating of Device 164
Device Operates Differently Than Expected 138
Leak/Splash 124
Component Missing 118
Mechanical Jam 92
Detachment Of Device Component 91
Metal Shedding Debris 86
Device Remains Activated 78
Component Falling 77
Nonstandard Device 75
Smoking 68
Unintended Power Up 67
Device Contamination with Chemical or Other Material 62
Temperature Problem 58
Battery Problem 46

Yearly Trend

97
1997: 2
98
1998: 1
00
2000: 2
01
2001: 17
02
2002: 17
03
2003: 7
04
2004: 5
05
2005: 3
06
2006: 4
07
2007: 10
08
2008: 4
09
2009: 265
10
2010: 424
11
2011: 1,080
12
2012: 615
13
2013: 288
14
2014: 36
15
2015: 36
16
2016: 11
17
2017: 1
18
2018: 1
19
2019: 1
20
2020: 1
22
2022: 4
23
2023: 6
24
2024: 8
25
2025: 4
26
2026: 6

Reports fell to 4 in 2025, down from an average of 7 in the two years before.

Related Entities for Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

Event Locations

2,790 (97.6%)
I 32 (1.1%)
HOSPITAL 31 (1.1%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)
NO INFORMATION 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare STRYKER INSTRUMENTS KALAMAZOO vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Instrument: 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 (2,859 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

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.