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2026 data FDA MAUDE openFDA FDA Class I

Accessories, Arthroscopic

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 §888.1100 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Accessories, Arthroscopic LIGHT-BOOK · MAUDE

#316 of 1000 · 5,126 reports · 2000–2026

  • BOOK 5,126 reports
  • RANK #316 of 1000
  • DEATH 0 death-typed
  • INJ 752 injury-typed
  • MALF 4,346 malfunction
  • SPAN 2000–2026
  • PEAK 2024: 676
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing (20 report gap)

Accessories, Arthroscopic sits #316 of 1000 among tracked device types with 5,126 MAUDE reports spanning 2000–2026. 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

Accessories, Arthroscopic carries 84.8% MALFUNCTION-coded reports, 20.0pp 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 14.7% corpus 30.3% · below corpus mean (-15.6 pp)
  • MALF 84.8% corpus 64.8% · above corpus mean (+20.0 pp)

Lead product-problem code Break is 49% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 36% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Accessories, Arthroscopic in the event-volume neighbourhood

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

reports

What this shows Accessories, Arthroscopic carries 5,126 MAUDE reports, ranked #316 of 1000.

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

Event Types

Malfunction 4,346 (84.8%)
Injury 752 (14.7%)
Other 20 (0.4%)
8 (0.2%)

Patient Outcomes

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

4,203 (81.5%)
Required Intervention 420 (8.1%)
Other 398 (7.7%)
R 76 (1.5%)
O 35 (0.7%)
Hospitalization 19 (0.4%)
Disability 2 (0.0%)
H 1 (0.0%)
S 1 (0.0%)
Congenital Anomaly 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Break 2,414
Detachment of Device or Device Component 312
Degraded 273
Material Deformation 223
Mechanical Jam 172
Material Twisted/Bent 171
Material Separation 166
Difficult to Open or Close 146
Detachment Of Device Component 136
Material Fragmentation 127
Fracture 109
Device Damaged by Another Device 105
Device Operates Differently Than Expected 93
Device-Device Incompatibility 79
Device Contaminated During Manufacture or Shipping 72
Use of Device Problem 67
Metal Shedding Debris 61
Tip breakage 59
Corroded 55
Device, or device fragments remain in patient 48

Yearly Trend

00
2000: 6
01
2001: 2
02
2002: 29
03
2003: 31
04
2004: 10
05
2005: 33
06
2006: 33
07
2007: 40
08
2008: 47
09
2009: 38
10
2010: 50
11
2011: 57
12
2012: 63
13
2013: 53
14
2014: 80
15
2015: 185
16
2016: 359
17
2017: 224
18
2018: 307
19
2019: 358
20
2020: 340
21
2021: 389
22
2022: 334
23
2023: 492
24
2024: 676
25
2025: 561
26
2026: 329

Reports in 2025 (561) held close to the prior two-year average of 584.

Related Entities for Accessories, Arthroscopic

Top Manufacturers

SMITH & NEPHEW, INC. 1,545
DEPUY MITEK LLC US 837
ARTHREX, INC. 796
STRYKER ENDOSCOPY-SAN JOSE 415
ARTHROCARE CORPORATION 320
ARTHROCARE CORP. 264
MEDOS INTERNATIONAL SARL 82
DEPUY MITEK 67

Event Locations

2,850 (55.6%)
I 1,854 (36.2%)
HOSPITAL 297 (5.8%)
NO INFORMATION 50 (1.0%)
AMBULATORY SURGICAL FACILITY 45 (0.9%)
OTHER 24 (0.5%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
HOME 1 (0.0%)
INVALID DATA 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare SMITH & NEPHEW, INC. vs DEPUY MITEK LLC US →

Nationwide devices with a comparable report-volume footprint

Accessories, Arthroscopic 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 (5,126 here).

Prosthesis 5,146 Tissue Expander And Accessories 5,148 Anesthesia Conduction Kit 5,152 Stimulator, Nerve 5,083

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0 Accessories, Photographic, For Endoscope 0

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

Disclaimer: MAUDE figures for Accessories, Arthroscopic 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 Accessories, Arthroscopic; 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.