2026 data FDA MAUDE openFDA FDA Class I

Wrench

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 Wrench LIGHT-BOOK · MAUDE

#554 of 1000 · 1,571 reports · 1995–2026

  • BOOK 1,571 reports
  • RANK #554 of 1000
  • DEATH 1 death-typed
  • INJ 75 injury-typed
  • MALF 1,489 malfunction
  • SPAN 1995–2026
  • PEAK 2021: 160
  • PHOTO Mattress

Nearest event-volume peer: Mattress, Flotation Therapy, Non-Powered (2 report gap)

Wrench sits #554 of 1000 among tracked device types with 1,571 MAUDE reports spanning 1995–2026. 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

Wrench carries 94.8% MALFUNCTION-coded reports, 30.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 4.8% corpus 30.3% · below corpus mean (-25.5 pp)
  • MALF 94.8% corpus 64.8% · above corpus mean (+30.0 pp)

Lead product-problem code Break is 25% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 26% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Wrench in the event-volume neighbourhood

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

reports

What this shows Wrench carries 1,571 MAUDE reports, ranked #554 of 1000.

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

Event Types

Malfunction 1,489 (94.8%)
Injury 75 (4.8%)
3 (0.2%)
Other 3 (0.2%)
Death 1 (0.1%)

Patient Outcomes

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

1,440 (92.1%)
Other 64 (4.1%)
Required Intervention 43 (2.8%)
R 6 (0.4%)
Hospitalization 6 (0.4%)
O 2 (0.1%)
Death 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 413
Calibration Problem 289
Device-Device Incompatibility 155
Fracture 145
Material Deformation 94
Mechanical Problem 84
Naturally Worn 67
Appropriate Device Problem Term/Code Not Available 51
Mechanical Jam 45
Crack 44
Material Twisted/Bent 41
Detachment of Device or Device Component 33
Material Integrity Problem 31
Device Operates Differently Than Expected 29
Component Missing 26
Unintended Movement 23
Corroded 20
Bent 15
Detachment Of Device Component 14
Scratched Material 14

Yearly Trend

95
1995: 2
96
1996: 3
97
1997: 7
98
1998: 8
99
1999: 1
01
2001: 1
03
2003: 1
04
2004: 2
05
2005: 1
06
2006: 2
07
2007: 3
08
2008: 9
09
2009: 7
10
2010: 8
11
2011: 5
12
2012: 13
13
2013: 50
14
2014: 18
15
2015: 34
16
2016: 100
17
2017: 118
18
2018: 111
19
2019: 154
20
2020: 142
21
2021: 160
22
2022: 143
23
2023: 145
24
2024: 125
25
2025: 117
26
2026: 81

Reports in 2025 (117) held close to the prior two-year average of 135.

Related Entities for Wrench

Event Locations

789 (50.2%)
I 743 (47.3%)
HOSPITAL 36 (2.3%)
INVALID DATA 1 (0.1%)
OTHER 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare DEPUY ORTHOPAEDICS INC US vs DEPUY SPINE INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Wrench: 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 (1,571 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Disclaimer: MAUDE figures for Wrench 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 Wrench; 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.