What are FDA adverse event reports for Tray, Surgical, Instrument?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Tray, Surgical, Instrument, there are 2,046 total reports including 2 death reports and 112 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Tray, Surgical, Instrument?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Tray, Surgical, Instrument

Name: Tray, Surgical, Instrument - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Tray, Surgical, Instrument LIGHT-BOOK · MAUDE

#478 of 1000 · 2,046 reports · 1992–2026

BOOK 2,046 reports
RANK #478 of 1000
DEATH 2 death-typed
INJ 112 injury-typed
MALF 1,922 malfunction
SPAN 1992–2026
PEAK 2024: 288
PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implanted, For Essential Tremor (4 report gap)

Tray, Surgical, Instrument sits #478 of 1000 among tracked device types with 2,046 MAUDE reports spanning 1992–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 5.5% corpus 30.4% · below corpus mean (-25.0 pp)
MALF 93.9% corpus 64.5% · above corpus mean (+29.4 pp)

Lead product-problem code Peeled/Delaminated is 38% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 28% of manufacturer-tagged reports · Top event location is 60% of location-tagged rows .

Bur

2,062
Agent

2,061
Ligator

2,053
Tray (this)

2,046
Stimulator

2,042
Light Source

2,036

What this shows Tray, Surgical, Instrument carries 2,046 MAUDE reports, ranked #478 of 1000.

Event Types

Malfunction 1,922 (93.9%)

Injury 112 (5.5%)

6 (0.3%)

Other 4 (0.2%)

Death 2 (0.1%)

Patient Outcomes

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

1,886 (92.1%)

Required Intervention 73 (3.6%)

Other 56 (2.7%)

Hospitalization 15 (0.7%)

R 6 (0.3%)

O 4 (0.2%)

Death 2 (0.1%)

Life Threatening 2 (0.1%)

L 1 (0.0%)

S 1 (0.0%)

Disability 1 (0.0%)

Yearly Trend

1992: 1

1996: 2

2000: 1

2002: 2

2003: 2

2004: 2

2005: 5

2006: 1

2007: 2

2008: 1

2010: 2

2011: 8

2012: 10

2013: 81

2014: 46

2015: 79

2016: 90

2017: 132

2018: 104

2019: 168

2020: 148

2021: 153

2022: 200

2023: 168

2024: 288

2025: 274

2026: 76

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 430

DEPUY IRELAND - 3015516266 357

DEPUY IRELAND - 9616671 232

SMITH & NEPHEW, INC. 218

DEPUY ORTHOPAEDICS, INC. 1818910 88

DEPUY ORTHOPAEDICS, INC. 59

SYNTHES USA 51

DEPUY SYNTHES POWER TOOLS 49

SYNTHES (USA) 37

Event Locations

1,219 (59.6%)

I 764 (37.3%)

HOSPITAL 45 (2.2%)

NO INFORMATION 17 (0.8%)

INVALID DATA 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 3015516266 →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tray, Surgical, Instrument, 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 (2,046 here).

Stimulator 2,042 Ligator, Hemorrhoidal 2,053 Light Source, Endoscope, Xenon Arc 2,036 Agent, Absorbable Hemostatic, Collagen Based 2,061

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

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

Disclaimer: MAUDE figures for Tray, Surgical, Instrument 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 Tray, Surgical, Instrument; 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.

Tray, Surgical, Instrument

Event-type mix vs corpus