2026 data FDA MAUDE openFDA FDA Class I

Broach

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).

FDA MAUDE casebook

openFDA event book Broach LIGHT-BOOK · MAUDE

#336 of 1000 · 4,622 reports · 1996–2026

  • BOOK 4,622 reports
  • RANK #336 of 1000
  • DEATH 2 death-typed
  • INJ 221 injury-typed
  • MALF 4,390 malfunction
  • SPAN 1996–2026
  • PEAK 2023: 576
  • PHOTO Snare, Flexible

Nearest event-volume peer: Snare, Flexible (18 report gap)

Broach sits #336 of 1000 among tracked device types with 4,622 MAUDE reports spanning 1996–2026. 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

Broach carries 95.0% MALFUNCTION-coded reports, 30.2pp 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 4.8% corpus 30.3% · below corpus mean (-25.5 pp)
  • MALF 95.0% corpus 64.8% · above corpus mean (+30.2 pp)

Lead product-problem code Device-Device Incompatibility is 31% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 38% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Broach in the event-volume neighbourhood

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

reports

What this shows Broach carries 4,622 MAUDE reports, ranked #336 of 1000.

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

Event Types

Malfunction 4,390 (95.0%)
Injury 221 (4.8%)
Other 8 (0.2%)
Death 2 (0.0%)
1 (0.0%)

Patient Outcomes

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

4,258 (92.0%)
Required Intervention 197 (4.3%)
Other 131 (2.8%)
R 20 (0.4%)
Hospitalization 16 (0.3%)
O 3 (0.1%)
Death 2 (0.0%)
S 1 (0.0%)
Disability 1 (0.0%)

Top Product Problems

Device-Device Incompatibility 1,635
Break 1,145
Unintended Movement 365
Material Deformation 267
Scratched Material 240
Failure to Cut 238
Naturally Worn 233
Appropriate Device Problem Term/Code Not Available 166
Loose or Intermittent Connection 135
Difficult to Advance 118
Fracture 111
Material Twisted/Bent 102
Adverse Event Without Identified Device or Use Problem 93
Structural Problem 92
Connection Problem 84
No Apparent Adverse Event 53
Dull, Blunt 51
Device Damaged Prior to Use 46
Material Integrity Problem 43
Mechanical Jam 38

Yearly Trend

96
1996: 12
97
1997: 36
98
1998: 35
99
1999: 7
00
2000: 6
01
2001: 11
02
2002: 8
03
2003: 12
04
2004: 9
05
2005: 11
06
2006: 12
07
2007: 17
08
2008: 22
09
2009: 25
10
2010: 22
11
2011: 18
12
2012: 6
13
2013: 12
14
2014: 3
16
2016: 73
17
2017: 225
18
2018: 433
19
2019: 460
20
2020: 466
21
2021: 550
22
2022: 504
23
2023: 576
24
2024: 470
25
2025: 310
26
2026: 271

Reports fell to 310 in 2025, down from an average of 523 in the two years before.

Related Entities for Broach

Event Locations

2,430 (52.6%)
I 2,066 (44.7%)
HOSPITAL 115 (2.5%)
INVALID DATA 4 (0.1%)
NOT APPLICABLE 4 (0.1%)
OTHER 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY IRELAND - 9616671 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Broach: 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 (4,622 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Broach 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 Broach; 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.