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2026 data FDA MAUDE openFDA

Instrument, Cutting, Orthopedic

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, Cutting, Orthopedic LIGHT-BOOK · MAUDE

#563 of 1000 · 1,465 reports · 1996–2026

  • BOOK 1,465 reports
  • RANK #563 of 1000
  • DEATH 0 death-typed
  • INJ 33 injury-typed
  • MALF 1,429 malfunction
  • SPAN 1996–2026
  • PEAK 2021: 228
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Parathyroid Hormone (0 report gap)

Instrument, Cutting, Orthopedic sits #563 of 1000 among tracked device types with 1,465 MAUDE reports spanning 1996–2026. 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 (-28.2 pp)
  • MALF 97.5% corpus 64.5% · above corpus mean (+33.0 pp)

Lead product-problem code Break is 28% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 40% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

Instrument, Cutting, Orthopedic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Instrument, Cutting, Orthopedic carries 1,465 MAUDE reports, ranked #563 of 1000.

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

Event Types

Malfunction 1,429 (97.5%)
Injury 33 (2.3%)
Other 2 (0.1%)
1 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,414 (96.7%)
Required Intervention 23 (1.6%)
Other 16 (1.1%)
Disability 3 (0.2%)
Hospitalization 3 (0.2%)
R 2 (0.1%)
O 1 (0.1%)

Top Product Problems

Break 441
Device-Device Incompatibility 286
Material Deformation 218
Naturally Worn 161
Failure to Cut 82
Scratched Material 69
Material Twisted/Bent 43
Mechanical Jam 39
Corroded 31
Material Integrity Problem 31
Crack 26
Physical Resistance/Sticking 22
Detachment of Device or Device Component 17
Contamination /Decontamination Problem 16
Adverse Event Without Identified Device or Use Problem 14
No Apparent Adverse Event 14
Appropriate Term/Code Not Available 13
Illegible Information 11
Mechanical Problem 11
Difficult to Remove 10

Yearly Trend

96
1996: 1
98
1998: 1
00
2000: 2
01
2001: 1
02
2002: 1
03
2003: 1
04
2004: 2
05
2005: 3
07
2007: 1
09
2009: 1
10
2010: 3
11
2011: 3
12
2012: 3
13
2013: 47
14
2014: 18
15
2015: 15
16
2016: 34
17
2017: 32
18
2018: 47
19
2019: 108
20
2020: 88
21
2021: 228
22
2022: 195
23
2023: 187
24
2024: 225
25
2025: 139
26
2026: 79

Related Entities for Instrument, Cutting, Orthopedic

Top Manufacturers

DEPUY IRELAND - 9616671 513
DEPUY ORTHOPAEDICS INC US 364
DEPUY INTERNATIONAL LTD - 8010379 99
SYNTHES GMBH 97
DEPUY SPINE INC 60
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 58
DEPUY IRELAND 9616671 29
DEPUY FRANCE SAS - 3003895575 27
DEPUY IRELAND - 3015516266 25
DEPUY ORTHOPAEDICS, INC. 1818910 21

Event Locations

995 (67.9%)
I 453 (30.9%)
HOSPITAL 13 (0.9%)
NO INFORMATION 3 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)

Compare DEPUY IRELAND - 9616671 vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Instrument, Cutting, Orthopedic, 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 (1,465 here).

Radioimmunoassay, Parathyroid Hormone 1,465 Lift, Patient, Ac-Powered 1,464 Patch 1,463 Indicator, Biological Sterilization Process 1,469

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Instrument, Cutting, Orthopedic 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, Cutting, Orthopedic; 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.