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2026 data FDA MAUDE openFDA FDA Class I

Instrument, Surgical, Orthopedic, Ac-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).

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FDA MAUDE casebook

openFDA event book Instrument MID-BOOK · MAUDE

#70 of 1000 · 50,267 reports · 1995–2026

  • BOOK 50,267 reports
  • RANK #70 of 1000
  • DEATH 7 death-typed
  • INJ 1,157 injury-typed
  • MALF 49,032 malfunction
  • SPAN 1995–2026
  • PEAK 2015: 5,567
  • PHOTO Interventional Fluoro…

Nearest event-volume peer: Interventional Fluoroscopic X-Ray System (285 report gap)

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment sits #70 of 1000 among tracked device types with 50,267 MAUDE reports spanning 1995–2026. 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 97.5% MALFUNCTION-coded reports, 32.7pp 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 2.3% corpus 30.3% · below corpus mean (-28.0 pp)
  • MALF 97.5% corpus 64.8% · above corpus mean (+32.7 pp)

Lead product-problem code Mechanical Jam is 13% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 30% of manufacturer-tagged reports · Top event location I is 52% 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, Ac-Powered Motor And Accessory/Attachment carries 50,267 MAUDE reports, ranked #70 of 1000.

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

Event Types

Malfunction 49,032 (97.5%)
Injury 1,157 (2.3%)
Other 55 (0.1%)
15 (0.0%)
Death 7 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

48,670 (96.8%)
Required Intervention 808 (1.6%)
Other 627 (1.2%)
R 62 (0.1%)
Hospitalization 51 (0.1%)
O 14 (0.0%)
Death 10 (0.0%)
Disability 9 (0.0%)
H 5 (0.0%)
S 4 (0.0%)
Life Threatening 3 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Mechanical Jam 6,567
Physical Resistance/Sticking 5,102
Break 4,107
Complete Loss of Power 3,772
Device Inoperable 3,450
Unintended System Motion 3,176
Noise, Audible 3,068
Device Operates Differently Than Expected 2,987
Output below Specifications 2,600
Fracture 2,220
Fail-Safe Problem 2,185
Overheating of Device 2,115
Excessive Heating 1,731
Detachment of Device or Device Component 1,472
Appropriate Device Problem Term/Code Not Available 1,332
Mechanical Problem 1,162
Partial Blockage 1,023
Disassembly 868
Sticking 751
Intermittent Loss of Power 745

Yearly Trend

95
1995: 9
96
1996: 6
97
1997: 11
98
1998: 10
99
1999: 9
00
2000: 27
01
2001: 30
02
2002: 10
03
2003: 15
04
2004: 22
05
2005: 88
06
2006: 178
07
2007: 123
08
2008: 72
09
2009: 180
10
2010: 297
11
2011: 138
12
2012: 221
13
2013: 1,243
14
2014: 3,794
15
2015: 5,567
16
2016: 4,974
17
2017: 5,074
18
2018: 3,589
19
2019: 3,452
20
2020: 3,248
21
2021: 3,140
22
2022: 3,327
23
2023: 3,397
24
2024: 3,686
25
2025: 2,882
26
2026: 1,448

Reports in 2025 (2,882) held close to the prior two-year average of 3,542.

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

Top Manufacturers

SYNTHES GMBH 13,449
DEPUY SYNTHES POWER TOOLS 9,219
DEPUY SYNTHES PRODUCTS LLC 7,344
STRYKER INSTRUMENTS-KALAMAZOO 5,007
SYNTHES OBERDORF 4,823
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2,314
ARTHREX, INC. 1,152
DEPUY ORTHOPAEDICS INC US 791
SMITH & NEPHEW, INC. 674
DEPUY IRELAND - 9616671 449

Event Locations

I 25,896 (51.5%)
23,905 (47.6%)
HOSPITAL 249 (0.5%)
NO INFORMATION 176 (0.4%)
OTHER 16 (0.0%)
AMBULATORY SURGICAL FACILITY 14 (0.0%)
INVALID DATA 5 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
UNKNOWN 2 (0.0%)

Compare SYNTHES GMBH vs DEPUY SYNTHES POWER TOOLS →

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 (50,267 here).

Interventional Fluoroscopic X-Ray System 49,982 Catheter 48,999 Tubes 48,656 Stimulator 51,898

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Joint, Temporomandibular, Implant 7 Mesh, Surgical, Absorbable, Abdominal Hernia 7

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.