PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Tray, Surgical, Instrument

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).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#470 of 1000 · 2,231 reports · 1992–2026

  • BOOK 2,231 reports
  • RANK #470 of 1000
  • DEATH 2 death-typed
  • INJ 113 injury-typed
  • MALF 2,106 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 288
  • PHOTO Implant

Nearest event-volume peer: Implant, Anti-Gastroesophageal Reflux (5 report gap)

Tray, Surgical, Instrument sits #470 of 1000 among tracked device types with 2,231 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 →

Malfunction reports run above the device-type norm

Tray, Surgical, Instrument carries 94.4% MALFUNCTION-coded reports, 29.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 5.1% corpus 30.3% · below corpus mean (-25.2 pp)
  • MALF 94.4% corpus 64.8% · above corpus mean (+29.6 pp)

Lead product-problem code Peeled/Delaminated is 39% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 28% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Tray, Surgical, Instrument in the event-volume neighbourhood

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

reports

What this shows Tray, Surgical, Instrument carries 2,231 MAUDE reports, ranked #470 of 1000.

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

Event Types

Malfunction 2,106 (94.4%)
Injury 113 (5.1%)
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.

2,065 (92.6%)
Required Intervention 75 (3.4%)
Other 59 (2.6%)
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%)

Top Product Problems

Peeled/Delaminated 974
Break 387
Contamination /Decontamination Problem 196
Crack 184
Naturally Worn 110
Delamination 100
Material Discolored 58
No Apparent Adverse Event 54
Material Twisted/Bent 52
Flaked 50
Fracture 43
Adverse Event Without Identified Device or Use Problem 41
Corroded 37
Material Deformation 34
Appropriate Device Problem Term/Code Not Available 32
Device Operates Differently Than Expected 28
Material Integrity Problem 28
Device Inoperable 27
Unsealed Device Packaging 26
Material Fragmentation 24

Yearly Trend

92
1992: 1
96
1996: 2
00
2000: 1
02
2002: 2
03
2003: 2
04
2004: 2
05
2005: 5
06
2006: 1
07
2007: 2
08
2008: 1
10
2010: 2
11
2011: 8
12
2012: 10
13
2013: 81
14
2014: 46
15
2015: 79
16
2016: 90
17
2017: 132
18
2018: 104
19
2019: 168
20
2020: 148
21
2021: 153
22
2022: 200
23
2023: 168
24
2024: 288
25
2025: 274
26
2026: 261

Reports in 2025 (274) held close to the prior two-year average of 228.

Related Entities for Tray, Surgical, Instrument

Top Manufacturers

DEPUY ORTHOPAEDICS INC US 477
DEPUY IRELAND - 3015516266 435
DEPUY IRELAND - 9616671 270
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

1,400 (62.8%)
I 764 (34.2%)
HOSPITAL 49 (2.2%)
NO INFORMATION 17 (0.8%)
INVALID DATA 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 3015516266 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tray, Surgical, Instrument: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,231 here).

Implant, Anti-Gastroesophageal Reflux 2,236 Stimulator 2,224 Warmer, Blood, Non-Electromagnetic Radiation 2,219 Forceps 2,217

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 Bed, Pediatric Open Hospital 2 Blade 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.