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Driver, Wire, And Bone Drill, Manual

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Driver, Wire, And Bone Drill, Manual

The FDA MAUDE database aggregates 3,390 adverse-event reports for Driver, Wire, And Bone Drill, Manual spanning the period from 1992 through 2026. Of these, 1 is classified as a death report, 111 as injury reports, and 3,273 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 7 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 Break topping the list at 30 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 22 years of MAUDE data, with the peak single-year volume reaching 809 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 6 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.

3,390
Total Reports
1
Death Reports
111
Injury Reports
3,273
Malfunctions

Event Types

Malfunction 3,273 (96.5%)
Injury 111 (3.3%)
3 (0.1%)
Other 2 (0.1%)
Death 1 (0.0%)

Patient Outcomes

3,275 (96.5%)
Other 73 (2.2%)
Required Intervention 37 (1.1%)
Hospitalization 3 (0.1%)
R 2 (0.1%)
Death 2 (0.1%)
O 1 (0.0%)

Top Product Problems

Break 30
Adverse Event Without Identified Device or Use Problem 21
Device Remains Activated 19
Unintended Power Up 16
Patient-Device Incompatibility 8
Inadequacy of Device Shape and/or Size 7
Entrapment of Device 6
Manufacturing, Packaging or Shipping Problem 6
Device-Device Incompatibility 5
Malposition of Device 5
Physical Resistance/Sticking 5
Device Markings/Labelling Problem 3
Inaccurate Information 3
Patient Device Interaction Problem 3
Defective Device 2
Device Displays Incorrect Message 2
Device Operates Differently Than Expected 2
Inadequate Instructions for Healthcare Professional 2
Insufficient Information 2
Labelling, Instructions for Use or Training Problem 2

Yearly Trend

92
1992: 2
96
1996: 1
05
2005: 1
08
2008: 10
09
2009: 142
10
2010: 517
11
2011: 578
12
2012: 621
13
2013: 809
14
2014: 539
15
2015: 18
16
2016: 16
17
2017: 9
18
2018: 8
19
2019: 4
20
2020: 17
21
2021: 22
22
2022: 23
23
2023: 22
24
2024: 13
25
2025: 14
26
2026: 4

Related Entities for Driver, Wire, And Bone Drill, Manual

Event Locations

3,290 (97.1%)
I 85 (2.5%)
HOSPITAL 9 (0.3%)
AMBULATORY SURGICAL FACILITY 2 (0.1%)
NO INFORMATION 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)

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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.