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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#45 of 1000 · 78,848 reports · 1994–2026

  • BOOK 78,848 reports
  • RANK #45 of 1000
  • DEATH 55 death-typed
  • INJ 7,436 injury-typed
  • MALF 70,896 malfunction
  • SPAN 1994–2026
  • PEAK 2016: 6,365
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implantable, For Incontinence (890 report gap)

Orthopedic Manual Surgical Instrument sits #45 of 1000 among tracked device types with 78,848 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 9.4% corpus 30.4% · below corpus mean (-21.0 pp)
  • MALF 89.9% corpus 64.5% · above corpus mean (+25.4 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS, INC. accounts for 18% of manufacturer-tagged reports · Top event location is 54% 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 78,848 MAUDE reports, ranked #45 of 1000.

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

Event Types

Malfunction 70,896 (89.9%)
Injury 7,436 (9.4%)
Other 298 (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.

61,578 (76.9%)
Other 11,406 (14.3%)
Required Intervention 4,673 (5.8%)
Hospitalization 960 (1.2%)
R 954 (1.2%)
O 144 (0.2%)
H 75 (0.1%)
S 67 (0.1%)
Disability 67 (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 21,830
Device-Device Incompatibility 5,671
Fracture 5,424
Material Deformation 2,741
Crack 1,892
Naturally Worn 1,846
Material Twisted/Bent 1,761
Detachment of Device or Device Component 1,648
Mechanical Jam 1,353
Appropriate Term/Code Not Available 1,290
Mechanics Altered 1,084
Mechanical Problem 973
Scratched Material 893
Material Fragmentation 873
Physical Resistance/Sticking 867
Material Integrity Problem 774
Calibration Problem 697
Adverse Event Without Identified Device or Use Problem 690
Corroded 581
Dull, Blunt 557

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: 5,944
16
2016: 6,365
17
2017: 4,133
18
2018: 4,685
19
2019: 5,224
20
2020: 4,766
21
2021: 4,832
22
2022: 4,844
23
2023: 5,163
24
2024: 6,319
25
2025: 6,200
26
2026: 944

Related Entities for Orthopedic Manual Surgical Instrument

Top Manufacturers

DEPUY ORTHOPAEDICS, INC. 6,682
DEPUY ORTHOPAEDICS INC US 4,920
ARTHREX, INC. 4,362
SYNTHES GMBH 4,035
DEPUY ORTHOPAEDICS, INC. 1818910 3,865
MEDTRONIC SOFAMOR DANEK USA, INC 3,089
SMITH & NEPHEW, INC. 3,080
DEPUY MITEK LLC US 2,819
WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2,371
ZIMMER BIOMET, INC. 2,198

Event Locations

42,926 (54.4%)
I 32,370 (41.1%)
HOSPITAL 3,216 (4.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Orthopedic Manual Surgical Instrument, 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 (78,848 here).

Stimulator 79,738 Laparoscope, General & Plastic Surgery 80,330 Intraocular Lens 77,018 Analyzer, Chemistry, For Clinical Use 76,746

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 Occluder, Patent Ductus, Arteriosus 54

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.