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2026 data FDA MAUDE openFDA FDA Class I

Blade, Saw, General & Plastic Surgery, Surgical

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 §878.4820 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Blade LIGHT-BOOK · MAUDE

#292 of 1000 · 5,861 reports · 1992–2026

  • BOOK 5,861 reports
  • RANK #292 of 1000
  • DEATH 2 death-typed
  • INJ 496 injury-typed
  • MALF 5,331 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 501
  • PHOTO Ultrasound Bronchosco…

Nearest event-volume peer: Ultrasound Bronchoscope (1 report gap)

Blade, Saw, General & Plastic Surgery, Surgical sits #292 of 1000 among tracked device types with 5,861 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

Blade carries 91.0% MALFUNCTION-coded reports, 26.1pp 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 8.5% corpus 30.3% · below corpus mean (-21.8 pp)
  • MALF 91.0% corpus 64.8% · above corpus mean (+26.1 pp)

Lead product-problem code Break is 34% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP accounts for 23% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Blade in the event-volume neighbourhood

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

reports

What this shows Blade, Saw, General & Plastic Surgery, Surgical carries 5,861 MAUDE reports, ranked #292 of 1000.

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

Event Types

Malfunction 5,331 (91.0%)
Injury 496 (8.5%)
17 (0.3%)
Other 14 (0.2%)
Death 2 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

5,276 (89.8%)
Other 373 (6.3%)
Required Intervention 169 (2.9%)
R 18 (0.3%)
Hospitalization 18 (0.3%)
O 8 (0.1%)
Disability 5 (0.1%)
L 3 (0.1%)
S 2 (0.0%)
Death 2 (0.0%)
H 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Break 1,785
Fracture 1,068
Material Fragmentation 472
Device Operates Differently Than Expected 366
Mechanical Jam 244
Device Inoperable 184
Detachment Of Device Component 144
Complete Loss of Power 137
Bent 104
Tear, Rip or Hole in Device Packaging 102
Delivered as Unsterile Product 94
Overheating of Device 79
Metal Shedding Debris 72
Component Missing 64
Dull, Blunt 64
Component Falling 61
Mechanical Problem 60
Smoking 60
Noise, Audible 59
Device Contaminated During Manufacture or Shipping 50

Yearly Trend

92
1992: 7
93
1993: 3
94
1994: 3
96
1996: 3
97
1997: 3
98
1998: 7
99
1999: 1
00
2000: 2
01
2001: 3
02
2002: 5
03
2003: 5
04
2004: 13
05
2005: 13
06
2006: 5
07
2007: 13
08
2008: 94
09
2009: 154
10
2010: 221
11
2011: 247
12
2012: 249
13
2013: 338
14
2014: 378
15
2015: 375
16
2016: 232
17
2017: 284
18
2018: 254
19
2019: 331
20
2020: 276
21
2021: 394
22
2022: 442
23
2023: 383
24
2024: 501
25
2025: 385
26
2026: 237

Reports in 2025 (385) held close to the prior two-year average of 442.

Related Entities for Blade, Saw, General & Plastic Surgery, Surgical

Top Manufacturers

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 840
STRYKER INSTRUMENTS-KALAMAZOO 600
STRYKER ENDOSCOPY-SAN JOSE 579
ARTHREX, INC. 562
SYNTHES GMBH 432
TERUMO CARDIOVASCULAR SYSTEMS CORP. 382
DEPUY SYNTHES POWER TOOLS 204
SYNTHES OBERDORF 108

Event Locations

3,802 (64.9%)
I 1,814 (31.0%)
HOSPITAL 167 (2.8%)
NO INFORMATION 50 (0.9%)
AMBULATORY SURGICAL FACILITY 15 (0.3%)
INVALID DATA 5 (0.1%)
OUTPATIENT TREATMENT FACILITY 5 (0.1%)
OTHER 3 (0.1%)

Compare STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP vs STRYKER INSTRUMENTS-KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Blade: 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 (5,861 here).

Ultrasound Bronchoscope 5,860 Stent, Ureteral 5,858 Drug-Eluting Peripheral Transluminal Angiop… 5,888 Holder, Head, Neurosurgical 5,826

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 Blood Pressure Cuff 2

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

Disclaimer: MAUDE figures for Blade 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 Blade; 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.