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

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FDA MAUDE adverse event data · 1995–2026

What the Data Shows About Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

The FDA MAUDE database aggregates 49,230 adverse-event reports for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment spanning the period from 1995 through 2026. Of these, 7 are classified as death reports, 1,137 as injury reports, and 48,015 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 6 distinct event types and 13 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Mechanical Jam topping the list at 5,716 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 32 years of MAUDE data, with the peak single-year volume reaching 5,567 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 9 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

49,230
Total Reports
7
Death Reports
1,137
Injury Reports
48,015
Malfunctions

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

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

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 →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.