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2026 data FDA MAUDE openFDA FDA Class II

Suture, Nonabsorbable, Synthetic, Polyethylene

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 §878.5000 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#141 of 1000 · 20,010 reports · 1997–2026

  • BOOK 20,010 reports
  • RANK #141 of 1000
  • DEATH 39 death-typed
  • INJ 5,438 injury-typed
  • MALF 14,482 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 3,001
  • PHOTO Leadless Pacemaker

Nearest event-volume peer: Leadless Pacemaker (46 report gap)

Suture, Nonabsorbable, Synthetic, Polyethylene sits #141 of 1000 among tracked device types with 20,010 MAUDE reports spanning 1997–2026. 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 72.4% MALFUNCTION-coded reports, 7.5pp 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 27.2% corpus 30.3% · below corpus mean (-3.1 pp)
  • MALF 72.4% corpus 64.8% · above corpus mean (+7.5 pp)

Lead product-problem code Failure to Fire is 18% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 69% of manufacturer-tagged reports · Top event location is 63% 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, Synthetic, Polyethylene carries 20,010 MAUDE reports, ranked #141 of 1000.

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

Event Types

Malfunction 14,482 (72.4%)
Injury 5,438 (27.2%)
Death 39 (0.2%)
Other 35 (0.2%)
16 (0.1%)

Patient Outcomes

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

13,824 (67.7%)
Required Intervention 3,364 (16.5%)
Other 2,324 (11.4%)
R 481 (2.4%)
O 212 (1.0%)
Hospitalization 99 (0.5%)
Death 34 (0.2%)
H 33 (0.2%)
Disability 15 (0.1%)
L 13 (0.1%)
S 9 (0.0%)
D 5 (0.0%)
Life Threatening 5 (0.0%)
Congenital Anomaly 3 (0.0%)

Top Product Problems

Failure to Fire 3,591
Break 3,159
Firing Problem 2,212
Device Dislodged or Dislocated 1,792
Adverse Event Without Identified Device or Use Problem 1,467
Premature Activation 1,097
Material Separation 1,013
Activation, Positioning or Separation Problem 850
Positioning Failure 780
Physical Resistance/Sticking 645
Detachment of Device or Device Component 614
Failure to Cycle 505
Device Operates Differently Than Expected 353
Material Twisted/Bent 302
Detachment Of Device Component 301
Failure to Advance 237
Insufficient Device Problem Information 206
Appropriate Device Problem Term/Code Not Available 179
Material Split, Cut or Torn 164
Patient Device Interaction Problem 152

Yearly Trend

97
1997: 1
98
1998: 1
99
1999: 2
00
2000: 1
01
2001: 2
02
2002: 1
04
2004: 8
05
2005: 8
06
2006: 7
07
2007: 15
08
2008: 15
09
2009: 55
10
2010: 79
11
2011: 97
12
2012: 253
13
2013: 210
14
2014: 165
15
2015: 626
16
2016: 688
17
2017: 1,104
18
2018: 1,453
19
2019: 1,251
20
2020: 1,224
21
2021: 1,643
22
2022: 1,419
23
2023: 2,038
24
2024: 2,597
25
2025: 3,001
26
2026: 2,046

Reports in 2025 (3,001) held close to the prior two-year average of 2,318.

Related Entities for Suture, Nonabsorbable, Synthetic, Polyethylene

Top Manufacturers

SMITH & NEPHEW, INC. 12,500
ETHICON INC. 2,893
ARTHREX, INC. 1,262
DAVIS & GECK CARIBE LTD 440
COVIDIEN LP LLC NORTH HAVEN 315
TELEFLEX MEDICAL 222
ARTHROCARE CORP. 210
ARTHROCARE CORPORATION 174
ARTHREX, INC. 140

Event Locations

12,665 (63.3%)
I 6,847 (34.2%)
HOSPITAL 326 (1.6%)
NO INFORMATION 88 (0.4%)
AMBULATORY SURGICAL FACILITY 36 (0.2%)
OTHER 27 (0.1%)
OUTPATIENT TREATMENT FACILITY 19 (0.1%)
CLINIC - WALK IN, OTHER 1 (0.0%)
HOME 1 (0.0%)

Compare SMITH & NEPHEW, INC. vs ETHICON INC. →

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 (20,010 here).

Leadless Pacemaker 19,964 Catheter, Intravascular, Diagnostic 20,128 Reagents 20,142 Dorsal Root Ganglion Stimulator For Pain Re… 19,735

Similar death-typed counts

Nearest other device types by death-typed report count (39 here), distinct from the volume row.

Airway, Oropharyngeal, Anesthesiology 39 System 39 Appliance, Fixation, Spinal Interlaminal 40 Applier, Surgical, Clip 40

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.