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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Instrument MID-BOOK · MAUDE

#69 of 1000 · 49,230 reports · 1995–2026

  • BOOK 49,230 reports
  • RANK #69 of 1000
  • DEATH 7 death-typed
  • INJ 1,137 injury-typed
  • MALF 48,015 malfunction
  • SPAN 1995–2026
  • PEAK 2015: 5,567
  • PHOTO Interventional Fluoro…

Nearest event-volume peer: Interventional Fluoroscopic X-Ray System (1,237 report gap)

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment sits #69 of 1000 among tracked device types with 49,230 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 →

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 2.3% corpus 30.4% · below corpus mean (-28.1 pp)
  • MALF 97.5% corpus 64.5% · above corpus mean (+33.0 pp)

Lead product-problem code Mechanical Jam is 14% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 29% of manufacturer-tagged reports · Top event location I is 53% 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 49,230 MAUDE reports, ranked #69 of 1000.

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

Event Types

Malfunction 48,015 (97.5%)
Injury 1,137 (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.

47,700 (96.8%)
Required Intervention 800 (1.6%)
Other 607 (1.2%)
R 62 (0.1%)
Hospitalization 50 (0.1%)
O 12 (0.0%)
Death 10 (0.0%)
Disability 9 (0.0%)
S 4 (0.0%)
H 3 (0.0%)
Life Threatening 3 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Mechanical Jam 5,716
Physical Resistance/Sticking 4,857
Complete Loss of Power 3,573
Unintended System Motion 3,149
Break 2,966
Noise, Audible 2,600
Output below Specifications 2,553
Fail-Safe Problem 2,174
Fracture 2,055
Excessive Heating 1,681
Device Operates Differently Than Expected 1,526
Overheating of Device 1,436
Detachment of Device or Device Component 1,378
Appropriate Term/Code Not Available 1,285
Device Inoperable 990
Mechanical Problem 889
Partial Blockage 752
Intermittent Loss of Power 712
Failure to Cut 702
Device-Device Incompatibility 617

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: 2,878
26
2026: 415

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

Top Manufacturers

SYNTHES GMBH 12,748
DEPUY SYNTHES POWER TOOLS 9,219
DEPUY SYNTHES PRODUCTS LLC 7,341
STRYKER INSTRUMENTS-KALAMAZOO 5,007
SYNTHES OBERDORF 4,823
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2,303
ARTHREX, INC. 1,068
DEPUY ORTHOPAEDICS INC US 772
SMITH & NEPHEW, INC. 663
DEPUY IRELAND - 9616671 445

Event Locations

I 25,896 (52.6%)
22,870 (46.5%)
HOSPITAL 247 (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 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 (49,230 here).

Interventional Fluoroscopic X-Ray System 47,993 Drug Eluting Permanent Left Ventricular Pac… 50,826 Syringe, Piston 51,034 Stimulator 51,263

Similar death-typed counts

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

Device, Warming. Blood And Plasma 7 Dressing, Wound, Occlusive 7 Image-Intensified Fluoroscopic X-Ray System 7 Intrauterine Tamponade Balloon 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.