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2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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 §878.4495 (General, Plastic Surgery panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Suture LIGHT-BOOK · MAUDE

#683 of 1000 · 936 reports · 1993–2026

  • BOOK 936 reports
  • RANK #683 of 1000
  • DEATH 7 death-typed
  • INJ 209 injury-typed
  • MALF 713 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 176
  • PHOTO Resectoscope

Nearest event-volume peer: Resectoscope (4 report gap)

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile sits #683 of 1000 among tracked device types with 936 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 →

Malfunction reports run above the device-type norm

Suture carries 76.2% MALFUNCTION-coded reports, 11.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.7% corpus 1.5% · below corpus mean (-0.8 pp)
  • INJ 22.3% corpus 30.3% · below corpus mean (-8.0 pp)
  • MALF 76.2% corpus 64.8% · above corpus mean (+11.3 pp)

Lead product-problem code Break is 37% of coded problems · Lead manufacturer ETHICON INC. accounts for 70% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Suture in the event-volume neighbourhood

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

reports

What this shows Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile carries 936 MAUDE reports, ranked #683 of 1000.

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

Event Types

Malfunction 713 (76.2%)
Injury 209 (22.3%)
Death 7 (0.7%)
4 (0.4%)
Other 3 (0.3%)

Patient Outcomes

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

694 (70.4%)
Required Intervention 154 (15.6%)
Other 57 (5.8%)
R 25 (2.5%)
Hospitalization 21 (2.1%)
O 9 (0.9%)
L 8 (0.8%)
Death 7 (0.7%)
H 6 (0.6%)
S 2 (0.2%)
Life Threatening 2 (0.2%)
Disability 1 (0.1%)

Top Product Problems

Break 353
Material Separation 298
Detachment of Device or Device Component 100
Adverse Event Without Identified Device or Use Problem 39
Other (for use when an appropriate device code cannot be identified) 26
Appropriate Device Problem Term/Code Not Available 19
Material Twisted/Bent 15
Suture line disruption 12
Dull, Blunt 10
Replace 10
Device Contaminated During Manufacture or Shipping 9
Unknown (for use when the device problem is not known) 9
Defective Component 7
Detachment Of Device Component 7
Bent 6
Explanted 6
Suture line separation 6
Delivered as Unsterile Product 5
Packaging Problem 5
Component(s), broken 4

Yearly Trend

93
1993: 2
94
1994: 1
95
1995: 1
96
1996: 7
97
1997: 14
98
1998: 4
99
1999: 3
00
2000: 6
01
2001: 3
02
2002: 9
03
2003: 10
04
2004: 2
05
2005: 4
06
2006: 4
07
2007: 7
08
2008: 4
09
2009: 7
10
2010: 13
11
2011: 19
12
2012: 10
13
2013: 16
14
2014: 18
15
2015: 17
16
2016: 23
17
2017: 11
18
2018: 53
19
2019: 76
20
2020: 52
21
2021: 39
22
2022: 70
23
2023: 100
24
2024: 176
25
2025: 86
26
2026: 69

Reports fell to 86 in 2025, down from an average of 138 in the two years before.

Related Entities for Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

Top Manufacturers

ETHICON INC. 593
DAVIS & GECK CARIBE LTD 158
ETHICON, INC. 59
UNITED STATES SURGICAL CORP. 12
B. BRAUN SURGICAL S.A. 11
ETHICON, INC 8
TELEFLEX MEDICAL 6

Event Locations

584 (62.4%)
I 228 (24.4%)
HOSPITAL 60 (6.4%)
OTHER 40 (4.3%)
NO INFORMATION 9 (1.0%)
INVALID DATA 8 (0.9%)
UNKNOWN 5 (0.5%)
HOME 2 (0.2%)

Compare ETHICON INC. vs DAVIS & GECK CARIBE LTD →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Suture: 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 (936 here).

Resectoscope 940 Absorbable Coronary Drug-Eluting Stent 929 Bed, Manual 928 Catheter Care Tray 944

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Device, Percutaneous Retrieval 7 Dressing, Wound, Occlusive 7 Instrument 7 Joint, Temporomandibular, Implant 7

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Suture 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 Suture; 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.