2026 data FDA MAUDE openFDA FDA Class II

Wire, Surgical

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 Wire, Surgical LIGHT-BOOK · MAUDE

#625 of 1000 · 1,199 reports · 1993–2026

  • BOOK 1,199 reports
  • RANK #625 of 1000
  • DEATH 2 death-typed
  • INJ 421 injury-typed
  • MALF 758 malfunction
  • SPAN 1993–2026
  • PEAK 2023: 140
  • PHOTO Stretcher

Nearest event-volume peer: Stretcher, Hand-Carried (13 report gap)

Wire, Surgical sits #625 of 1000 among tracked device types with 1,199 MAUDE reports spanning 1993–2026. 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

Wire, Surgical carries 35.1% INJURY-coded reports, 4.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 35.1% corpus 30.3% · above corpus mean (+4.8 pp)
  • MALF 63.2% corpus 64.8% · below corpus mean (-1.6 pp)

Lead product-problem code Break is 32% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 57% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Wire, Surgical in the event-volume neighbourhood

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

reports

What this shows Wire, Surgical carries 1,199 MAUDE reports, ranked #625 of 1000.

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

Event Types

Malfunction 758 (63.2%)
Injury 421 (35.1%)
9 (0.8%)
Other 9 (0.8%)
Death 2 (0.2%)

Patient Outcomes

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

720 (59.6%)
Required Intervention 381 (31.5%)
Other 66 (5.5%)
R 18 (1.5%)
Hospitalization 15 (1.2%)
O 4 (0.3%)
Death 3 (0.2%)
D 1 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Break 423
Material Deformation 224
Adverse Event Without Identified Device or Use Problem 151
Device-Device Incompatibility 131
Entrapment of Device 111
Material Fragmentation 52
Difficult to Remove 29
Explanted 25
Device Operates Differently Than Expected 21
Insufficient Device Problem Information 20
No Apparent Adverse Event 18
Bent 16
Device, or device fragments remain in patient 16
Migration or Expulsion of Device 15
Wire(s), breakage of 14
Mechanical Jam 13
Component(s), broken 12
Tip breakage 12
Fracture 11
Replace 11

Yearly Trend

93
1993: 2
94
1994: 1
95
1995: 3
96
1996: 5
97
1997: 4
98
1998: 16
99
1999: 2
01
2001: 3
02
2002: 7
03
2003: 6
04
2004: 5
05
2005: 3
06
2006: 9
07
2007: 3
08
2008: 20
09
2009: 31
10
2010: 13
11
2011: 6
12
2012: 25
13
2013: 108
14
2014: 57
15
2015: 24
16
2016: 38
17
2017: 33
18
2018: 58
19
2019: 84
20
2020: 68
21
2021: 118
22
2022: 106
23
2023: 140
24
2024: 87
25
2025: 83
26
2026: 31

Reports in 2025 (83) held close to the prior two-year average of 114.

Related Entities for Wire, Surgical

Event Locations

746 (62.2%)
I 375 (31.3%)
HOSPITAL 62 (5.2%)
AMBULATORY SURGICAL FACILITY 5 (0.4%)
NO INFORMATION 4 (0.3%)
HOME 2 (0.2%)
INVALID DATA 2 (0.2%)
UNKNOWN 2 (0.2%)
OTHER 1 (0.1%)

Compare SYNTHES GMBH vs SYNTHES USA →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Wire, Surgical: 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 (1,199 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 Wire, Surgical 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 Wire, Surgical; 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.