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2026 data FDA MAUDE openFDA FDA Class I

Orthopedic Manual 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 §888.4540 (Orthopedic panel).

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FDA MAUDE casebook

openFDA event book Orthopedic Manual Surgical Instrument MID-BOOK · MAUDE

#46 of 1000 · 81,214 reports · 1994–2026

  • BOOK 81,214 reports
  • RANK #46 of 1000
  • DEATH 55 death-typed
  • INJ 7,525 injury-typed
  • MALF 73,172 malfunction
  • SPAN 1994–2026
  • PEAK 2016: 6,364
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implantable, For Incontinence (1,341 report gap)

Orthopedic Manual Surgical Instrument sits #46 of 1000 among tracked device types with 81,214 MAUDE reports spanning 1994–2026. 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

Orthopedic Manual Surgical Instrument carries 90.1% MALFUNCTION-coded reports, 25.3pp 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 9.3% corpus 30.3% · below corpus mean (-21.0 pp)
  • MALF 90.1% corpus 64.8% · above corpus mean (+25.3 pp)

Lead product-problem code Break is 46% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 17% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Orthopedic Manual Surgical Instrument in the event-volume neighbourhood

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

reports

What this shows Orthopedic Manual Surgical Instrument carries 81,214 MAUDE reports, ranked #46 of 1000.

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

Event Types

Malfunction 73,172 (90.1%)
Injury 7,525 (9.3%)
Other 299 (0.4%)
163 (0.2%)
Death 55 (0.1%)

Patient Outcomes

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

63,663 (77.4%)
Other 11,510 (14.0%)
Required Intervention 4,700 (5.7%)
Hospitalization 968 (1.2%)
R 960 (1.2%)
O 146 (0.2%)
H 78 (0.1%)
S 68 (0.1%)
Disability 68 (0.1%)
Death 55 (0.1%)
L 19 (0.0%)
Life Threatening 17 (0.0%)
Congenital Anomaly 7 (0.0%)
D 2 (0.0%)

Top Product Problems

Break 35,341
Fracture 6,903
Device-Device Incompatibility 6,072
Material Deformation 3,170
Crack 2,613
Appropriate Device Problem Term/Code Not Available 2,435
Detachment Of Device Component 2,245
Detachment of Device or Device Component 2,063
Naturally Worn 1,990
Material Twisted/Bent 1,867
Mechanical Jam 1,824
Device Operates Differently Than Expected 1,657
Mechanics Altered 1,245
Mechanical Problem 1,241
Material Integrity Problem 1,127
Material Fragmentation 1,105
Difficult to Remove 1,080
Scratched Material 926
Physical Resistance/Sticking 920
Tip breakage 895

Yearly Trend

94
1994: 5
95
1995: 7
96
1996: 55
97
1997: 185
98
1998: 260
99
1999: 87
00
2000: 52
01
2001: 58
02
2002: 111
03
2003: 128
04
2004: 173
05
2005: 312
06
2006: 328
07
2007: 398
08
2008: 833
09
2009: 1,569
10
2010: 2,329
11
2011: 2,489
12
2012: 2,059
13
2013: 4,147
14
2014: 3,844
15
2015: 5,943
16
2016: 6,364
17
2017: 4,133
18
2018: 4,684
19
2019: 5,224
20
2020: 4,765
21
2021: 4,832
22
2022: 4,844
23
2023: 5,163
24
2024: 6,319
25
2025: 6,198
26
2026: 3,316

Reports in 2025 (6,198) held close to the prior two-year average of 5,741.

Related Entities for Orthopedic Manual Surgical Instrument

Top Manufacturers

DEPUY ORTHOPAEDICS, INC. 6,681
DEPUY ORTHOPAEDICS INC US 5,158
ARTHREX, INC. 4,709
SYNTHES GMBH 4,222
DEPUY ORTHOPAEDICS, INC. 1818910 3,863
SMITH & NEPHEW, INC. 3,163
MEDTRONIC SOFAMOR DANEK USA, INC 3,089
DEPUY MITEK LLC US 2,873
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2,371
DEPUY IRELAND - 9616671 2,321

Event Locations

45,307 (55.8%)
I 32,350 (39.8%)
HOSPITAL 3,221 (4.0%)
NO INFORMATION 181 (0.2%)
OTHER 47 (0.1%)
AMBULATORY SURGICAL FACILITY 28 (0.0%)
INVALID DATA 25 (0.0%)
UNKNOWN 23 (0.0%)
NOT APPLICABLE 22 (0.0%)
HOME 4 (0.0%)
OUTPATIENT TREATMENT FACILITY 4 (0.0%)
HOSPICE 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS, INC. vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Orthopedic Manual 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 (81,214 here).

Stimulator 82,555 Intraocular Lens 79,358 Laparoscope, General & Plastic Surgery 83,414 Analyzer, Chemistry, For Clinical Use 78,872

Similar death-typed counts

Nearest other device types by death-typed report count (55 here), distinct from the volume row.

Bottle, Collection, Vacuum 55 Catheter, Balloon Type 55 Stent, Metallic, Expandable, Duodenal 55 Wheelchair, Mechanical 55

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

Disclaimer: MAUDE figures for Orthopedic Manual 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 Orthopedic Manual 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.