2026 data FDA MAUDE openFDA FDA Class II

Washer, Bolt Nut

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 II (moderate risk, special controls required), regulated under 21 CFR §888.3030 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Washer, Bolt Nut LIGHT-BOOK · MAUDE

#574 of 1000 · 1,494 reports · 1992–2026

  • BOOK 1,494 reports
  • RANK #574 of 1000
  • DEATH 2 death-typed
  • INJ 702 injury-typed
  • MALF 767 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 269
  • PHOTO Endoscope, Rigid

Nearest event-volume peer: Endoscope, Rigid (1 report gap)

Washer, Bolt Nut sits #574 of 1000 among tracked device types with 1,494 MAUDE reports spanning 1992–2026. 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 →

Injury-coded reports run above the device-type norm

Washer, Bolt Nut carries 47.0% INJURY-coded reports, 16.7pp 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 47.0% corpus 30.3% · above corpus mean (+16.7 pp)
  • MALF 51.3% corpus 64.8% · below corpus mean (-13.5 pp)

Lead product-problem code Break is 35% of coded problems · Lead manufacturer ARTHREX, INC. accounts for 57% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Washer, Bolt Nut in the event-volume neighbourhood

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

reports

What this shows Washer, Bolt Nut carries 1,494 MAUDE reports, ranked #574 of 1000.

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

Event Types

Malfunction 767 (51.3%)
Injury 702 (47.0%)
Other 20 (1.3%)
3 (0.2%)
Death 2 (0.1%)

Patient Outcomes

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

752 (49.4%)
Required Intervention 384 (25.2%)
Other 312 (20.5%)
R 36 (2.4%)
Hospitalization 23 (1.5%)
O 6 (0.4%)
H 3 (0.2%)
S 2 (0.1%)
Disability 2 (0.1%)
D 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Break 477
Adverse Event Without Identified Device or Use Problem 222
Device-Device Incompatibility 81
Insufficient Device Problem Information 62
Detachment of Device or Device Component 61
Material Split, Cut or Torn 52
Patient Device Interaction Problem 47
Device Dislodged or Dislocated 45
Positioning Failure 44
Device Slipped 37
Explanted 35
Appropriate Device Problem Term/Code Not Available 32
Use of Device Problem 28
Difficult to Advance 27
Migration 26
Entrapment of Device 24
Fracture 23
Device Operates Differently Than Expected 20
Defective Device 19
Physical Resistance/Sticking 18

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 1
96
1996: 5
97
1997: 4
98
1998: 2
99
1999: 3
00
2000: 1
01
2001: 2
02
2002: 3
03
2003: 2
04
2004: 4
05
2005: 7
06
2006: 10
07
2007: 14
08
2008: 11
09
2009: 22
10
2010: 17
11
2011: 12
12
2012: 69
13
2013: 45
14
2014: 33
15
2015: 35
16
2016: 43
17
2017: 30
18
2018: 48
19
2019: 53
20
2020: 81
21
2021: 149
22
2022: 85
23
2023: 108
24
2024: 269
25
2025: 194
26
2026: 130

Reports in 2025 (194) held close to the prior two-year average of 189.

Related Entities for Washer, Bolt Nut

Event Locations

1,063 (71.2%)
I 380 (25.4%)
HOSPITAL 38 (2.5%)
NO INFORMATION 7 (0.5%)
AMBULATORY SURGICAL FACILITY 3 (0.2%)
INVALID DATA 2 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Compare ARTHREX, INC. vs SYNTHES GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Washer, Bolt Nut: 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 (1,494 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 Washer, Bolt Nut 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 Washer, Bolt Nut; 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.