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Drills, Burrs, Trephines & Accessories (Simple, Powered)

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FDA MAUDE adverse event data · 1993–2026

What the Data Shows About Drills, Burrs, Trephines & Accessories (Simple, Powered)

The FDA MAUDE database aggregates 16,522 adverse-event reports for Drills, Burrs, Trephines & Accessories (Simple, Powered) spanning the period from 1993 through 2026. Of these, 3 are classified as death reports, 679 as injury reports, and 15,800 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 12 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 Overheating of Device topping the list at 4,073 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 30 years of MAUDE data, with the peak single-year volume reaching 1,944 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 11 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.

16,522
Total Reports
3
Death Reports
679
Injury Reports
15,800
Malfunctions

Event Types

Malfunction 15,800 (95.6%)
Injury 679 (4.1%)
20 (0.1%)
Other 20 (0.1%)
Death 3 (0.0%)

Patient Outcomes

15,504 (94.9%)
Other 408 (2.5%)
Required Intervention 318 (1.9%)
R 38 (0.2%)
Hospitalization 35 (0.2%)
O 12 (0.1%)
Disability 11 (0.1%)
Death 9 (0.1%)
Congenital Anomaly 3 (0.0%)
S 2 (0.0%)
Life Threatening 2 (0.0%)
L 1 (0.0%)

Top Product Problems

Overheating of Device 4,073
Fracture 2,148
Flaked 1,398
Break 887
Vibration 490
Detachment of Device or Device Component 386
Excessive Heating 262
No Apparent Adverse Event 250
Material Fragmentation 207
Noise, Audible 204
Disassembly 94
Material Twisted/Bent 91
Bent 86
Mechanical Problem 82
Device Remains Activated 70
Mechanical Jam 70
Naturally Worn 69
Fluid/Blood Leak 67
Physical Resistance/Sticking 65
Device Alarm System 55

Yearly Trend

93
1993: 1
94
1994: 1
97
1997: 5
00
2000: 36
01
2001: 252
02
2002: 31
03
2003: 18
04
2004: 24
05
2005: 34
06
2006: 12
07
2007: 14
08
2008: 14
09
2009: 242
10
2010: 492
11
2011: 1,013
12
2012: 1,146
13
2013: 1,583
14
2014: 559
15
2015: 483
16
2016: 849
17
2017: 848
18
2018: 787
19
2019: 836
20
2020: 1,025
21
2021: 1,047
22
2022: 900
23
2023: 948
24
2024: 1,153
25
2025: 1,944
26
2026: 225

Related Entities for Drills, Burrs, Trephines & Accessories (Simple, Powered)

Event Locations

10,616 (64.3%)
I 5,485 (33.2%)
HOSPITAL 383 (2.3%)
NO INFORMATION 27 (0.2%)
OTHER 5 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
INVALID DATA 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OPERATING ROOM 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 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.