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

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FDA MAUDE adverse event data · 1997–2026

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

The FDA MAUDE database aggregates 2,855 adverse-event reports for Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment spanning the period from 1997 through 2026. Of these, 2 are classified as death reports, 75 as injury reports, and 2,776 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 5 distinct event types and 4 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 Device-Device Incompatibility topping the list at 12 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 28 years of MAUDE data, with the peak single-year volume reaching 1,080 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 7 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.

2,855
Total Reports
2
Death Reports
75
Injury Reports
2,776
Malfunctions

Event Types

Malfunction 2,776 (97.2%)
Injury 75 (2.6%)
Death 2 (0.1%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

2,786 (97.6%)
Required Intervention 50 (1.8%)
Other 18 (0.6%)
Hospitalization 1 (0.0%)

Top Product Problems

Device-Device Incompatibility 12
Unintended Movement 5
Disassembly 4
Fluid/Blood Leak 4
Break 3
Device Dislodged or Dislocated 2
Overheating of Device 2
Corroded 1
Defective Device 1
Detachment Of Device Component 1
Detachment of Device or Device Component 1
Device Fell 1
Device Operates Differently Than Expected 1
Electrical /Electronic Property Problem 1
Entrapment of Device 1
Failure to Clean Adequately 1
Fracture 1
Insufficient Information 1
Mechanical Jam 1
Protective Measures Problem 1

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: 2

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Event Locations

2,786 (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%)

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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.