2026 data FDA MAUDE openFDA FDA Class I

Cutter, Wire

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 Cutter, Wire LIGHT-BOOK · MAUDE

#881 of 1000 · 510 reports · 1994–2026

  • BOOK 510 reports
  • RANK #881 of 1000
  • DEATH 0 death-typed
  • INJ 27 injury-typed
  • MALF 477 malfunction
  • SPAN 1994–2026
  • PEAK 2013: 54
  • PHOTO Tubing

Nearest event-volume peer: Tubing, Pressure And Accessories (0 report gap)

Cutter, Wire sits #881 of 1000 among tracked device types with 510 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

Cutter, Wire carries 93.5% MALFUNCTION-coded reports, 28.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.3% corpus 30.3% · below corpus mean (-25.0 pp)
  • MALF 93.5% corpus 64.8% · above corpus mean (+28.7 pp)

Lead product-problem code Break is 58% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 53% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Cutter, Wire in the event-volume neighbourhood

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

reports

What this shows Cutter, Wire carries 510 MAUDE reports, ranked #881 of 1000.

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

Event Types

Malfunction 477 (93.5%)
Injury 27 (5.3%)
Other 4 (0.8%)
2 (0.4%)

Patient Outcomes

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

467 (90.3%)
Required Intervention 20 (3.9%)
Other 15 (2.9%)
R 7 (1.4%)
Hospitalization 6 (1.2%)
S 1 (0.2%)
Invalid Data 1 (0.2%)

Top Product Problems

Break 315
Fracture 35
Material Integrity Problem 35
Detachment Of Device Component 17
Failure to Cut 16
Material Fragmentation 16
Dull, Blunt 14
Detachment of Device or Device Component 13
Component(s), broken 11
Crack 8
Device Operates Differently Than Expected 8
Material Deformation 8
Tip breakage 8
Component Falling 7
Component Missing 7
Corroded 7
Material Twisted/Bent 6
Mechanical Problem 6
Component(s), worn 4
Contamination /Decontamination Problem 4

Yearly Trend

94
1994: 1
96
1996: 3
97
1997: 5
98
1998: 2
00
2000: 7
01
2001: 7
02
2002: 3
03
2003: 11
04
2004: 3
07
2007: 6
08
2008: 6
10
2010: 1
11
2011: 4
12
2012: 6
13
2013: 54
14
2014: 29
15
2015: 24
16
2016: 33
17
2017: 25
18
2018: 26
19
2019: 36
20
2020: 24
21
2021: 44
22
2022: 37
23
2023: 33
24
2024: 34
25
2025: 33
26
2026: 13

Reports in 2025 (33) held close to the prior two-year average of 34.

Related Entities for Cutter, Wire

Event Locations

264 (51.8%)
I 189 (37.1%)
HOSPITAL 53 (10.4%)
INVALID DATA 3 (0.6%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable report-volume footprint

Cutter, Wire carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Disclaimer: MAUDE figures for Cutter, Wire 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 Cutter, Wire; 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.