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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Blade LIGHT-BOOK · MAUDE

#290 of 1000 · 5,683 reports · 1992–2026

  • BOOK 5,683 reports
  • RANK #290 of 1000
  • DEATH 2 death-typed
  • INJ 480 injury-typed
  • MALF 5,169 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 501
  • PHOTO Drug-Eluting Peripher…

Nearest event-volume peer: Drug-Eluting Peripheral Transluminal Angioplasty Catheter (9 report gap)

Blade, Saw, General & Plastic Surgery, Surgical sits #290 of 1000 among tracked device types with 5,683 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 8.4% corpus 30.4% · below corpus mean (-22.0 pp)
  • MALF 91.0% corpus 64.5% · above corpus mean (+26.4 pp)

Lead product-problem code Fracture is 29% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP accounts for 22% of manufacturer-tagged reports · Top event location is 64% 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 5,683 MAUDE reports, ranked #290 of 1000.

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

Event Types

Malfunction 5,169 (91.0%)
Injury 480 (8.4%)
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.

5,129 (89.8%)
Other 361 (6.3%)
Required Intervention 165 (2.9%)
R 18 (0.3%)
Hospitalization 18 (0.3%)
O 7 (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

Fracture 1,001
Break 986
Material Fragmentation 398
Mechanical Jam 200
Complete Loss of Power 137
Delivered as Unsterile Product 84
Device Operates Differently Than Expected 74
Dull, Blunt 55
Tear, Rip or Hole in Device Packaging 55
Smoking 53
Overheating of Device 48
Detachment Of Device Component 42
Device Contaminated During Manufacture or Shipping 42
Packaging Problem 39
Detachment of Device or Device Component 35
Device Inoperable 31
Failure to Cut 30
Device Contamination with Chemical or Other Material 29
Appropriate Term/Code Not Available 28
Excessive Heating 28

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: 59

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

Top Manufacturers

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 795
STRYKER INSTRUMENTS-KALAMAZOO 600
STRYKER ENDOSCOPY-SAN JOSE 559
ARTHREX, INC. 517
SYNTHES GMBH 415
TERUMO CARDIOVASCULAR SYSTEMS CORP. 382
DEPUY SYNTHES POWER TOOLS 204
SYNTHES OBERDORF 108

Event Locations

3,631 (63.9%)
I 1,814 (31.9%)
HOSPITAL 163 (2.9%)
NO INFORMATION 50 (0.9%)
AMBULATORY SURGICAL FACILITY 14 (0.2%)
INVALID DATA 5 (0.1%)
OTHER 3 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Blade, 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 (5,683 here).

Drug-Eluting Peripheral Transluminal Angiop… 5,692 Extended Depth Of Focus Intraocular Lens 5,658 Holder, Head, Neurosurgical 5,752 Suture, Nonabsorbable, Synthetic, Polyamide 5,613

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 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.