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2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Instrument, Cutting, Orthopedic LIGHT-BOOK · MAUDE

#572 of 1000 · 1,496 reports · 1996–2026

  • BOOK 1,496 reports
  • RANK #572 of 1000
  • DEATH 0 death-typed
  • INJ 33 injury-typed
  • MALF 1,460 malfunction
  • SPAN 1996–2026
  • PEAK 2021: 228
  • PHOTO Endoscope, Rigid

Nearest event-volume peer: Endoscope, Rigid (1 report gap)

Instrument, Cutting, Orthopedic sits #572 of 1000 among tracked device types with 1,496 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 →

Malfunction reports run above the device-type norm

Instrument, Cutting, Orthopedic carries 97.6% MALFUNCTION-coded reports, 32.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 2.2% corpus 30.3% · below corpus mean (-28.1 pp)
  • MALF 97.6% corpus 64.8% · above corpus mean (+32.8 pp)

Lead product-problem code Break is 32% of coded problems · Lead manufacturer DEPUY IRELAND - 9616671 accounts for 39% of manufacturer-tagged reports · Top event location is 69% 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 1,496 MAUDE reports, ranked #572 of 1000.

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

Event Types

Malfunction 1,460 (97.6%)
Injury 33 (2.2%)
Other 2 (0.1%)
1 (0.1%)

Patient Outcomes

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

1,449 (96.8%)
Required Intervention 23 (1.5%)
Other 16 (1.1%)
Disability 3 (0.2%)
Hospitalization 3 (0.2%)
R 2 (0.1%)
O 1 (0.1%)

Top Product Problems

Break 536
Device-Device Incompatibility 288
Material Deformation 221
Naturally Worn 162
Failure to Cut 82
Scratched Material 69
Material Twisted/Bent 43
Mechanical Jam 42
Corroded 34
Material Integrity Problem 32
Crack 26
Detachment of Device or Device Component 22
Physical Resistance/Sticking 22
Contamination /Decontamination Problem 16
No Apparent Adverse Event 15
Adverse Event Without Identified Device or Use Problem 14
Appropriate Device Problem Term/Code Not Available 12
Detachment Of Device Component 12
Mechanical Problem 12
Illegible Information 11

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: 33
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: 111

Reports in 2025 (139) held close to the prior two-year average of 206.

Related Entities for Instrument, Cutting, Orthopedic

Top Manufacturers

DEPUY IRELAND - 9616671 517
DEPUY ORTHOPAEDICS INC US 372
SYNTHES GMBH 107
DEPUY INTERNATIONAL LTD - 8010379 99
DEPUY SPINE INC 66
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 58
DEPUY IRELAND 9616671 29
DEPUY FRANCE SAS - 3003895575 27
DEPUY IRELAND - 3015516266 26
DEPUY ORTHOPAEDICS, INC. 1818910 21

Event Locations

1,027 (68.6%)
I 452 (30.2%)
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 a comparable report-volume footprint

Instrument, Cutting, Orthopedic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,496 here).

Endoscope, Rigid 1,495 Patch 1,498 Washer, Bolt Nut 1,494 Sterilizer, Steam 1,502

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.