PlainHospital
2026 data FDA MAUDE openFDA

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Suture MID-BOOK · MAUDE

#141 of 1000 · 18,497 reports · 1997–2026

  • BOOK 18,497 reports
  • RANK #141 of 1000
  • DEATH 39 death-typed
  • INJ 5,257 injury-typed
  • MALF 13,152 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 3,002
  • PHOTO Suture

Nearest event-volume peer: Suture, Nonabsorbable, Synthetic, Polypropylene (21 report gap)

Suture, Nonabsorbable, Synthetic, Polyethylene sits #141 of 1000 among tracked device types with 18,497 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 28.4% corpus 30.4% · below corpus mean (-2.0 pp)
  • MALF 71.1% corpus 64.5% · above corpus mean (+6.6 pp)

Lead product-problem code Failure to Fire is 19% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 68% of manufacturer-tagged reports · Top event location is 60% 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 18,497 MAUDE reports, ranked #141 of 1000.

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

Event Types

Malfunction 13,152 (71.1%)
Injury 5,257 (28.4%)
Death 39 (0.2%)
Other 33 (0.2%)
16 (0.1%)

Patient Outcomes

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

12,794 (66.7%)
Required Intervention 3,261 (17.0%)
Other 2,219 (11.6%)
R 481 (2.5%)
O 208 (1.1%)
Hospitalization 98 (0.5%)
Death 34 (0.2%)
H 28 (0.1%)
Disability 15 (0.1%)
L 12 (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 3,165
Break 2,637
Firing Problem 2,019
Device Dislodged or Dislocated 1,464
Adverse Event Without Identified Device or Use Problem 1,377
Material Separation 971
Premature Activation 971
Activation, Positioning or Separation Problem 647
Positioning Failure 570
Detachment of Device or Device Component 562
Physical Resistance/Sticking 516
Failure to Cycle 401
Failure to Advance 213
Device Operates Differently Than Expected 210
Material Twisted/Bent 201
Detachment Of Device Component 180
Appropriate Term/Code Not Available 156
Insufficient Information 152
Material Split, Cut or Torn 146
Unintended Ejection 113

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: 1,225
21
2021: 1,643
22
2022: 1,419
23
2023: 2,038
24
2024: 2,598
25
2025: 3,002
26
2026: 530

Related Entities for Suture, Nonabsorbable, Synthetic, Polyethylene

Top Manufacturers

SMITH & NEPHEW, INC. 11,455
ETHICON INC. 2,770
ARTHREX, INC. 1,091
DAVIS & GECK CARIBE LTD 424
COVIDIEN LP LLC NORTH HAVEN 315
TELEFLEX MEDICAL 220
ARTHROCARE CORP. 210
ARTHROCARE CORPORATION 174
ARTHREX, INC. 140

Event Locations

11,142 (60.2%)
I 6,859 (37.1%)
HOSPITAL 324 (1.8%)
NO INFORMATION 88 (0.5%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Suture, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (18,497 here).

Suture 18,518 Tube, Tracheal 18,473 Impactor 18,375 Dorsal Root Ganglion Stimulator For Pain Re… 18,878

Similar death-typed counts

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

Airway, Oropharyngeal, Anesthesiology 39 Stimulator 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.