2026 data FDA MAUDE openFDA FDA Class I

Pliers, 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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4800 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Pliers, Surgical LIGHT-BOOK · MAUDE

#957 of 1000 · 412 reports · 2000–2026

  • BOOK 412 reports
  • RANK #957 of 1000
  • DEATH 0 death-typed
  • INJ 15 injury-typed
  • MALF 390 malfunction
  • SPAN 2000–2026
  • PEAK 2013: 87
  • PHOTO Manometer

Nearest event-volume peer: Manometer, Spinal-Fluid (1 report gap)

Pliers, Surgical sits #957 of 1000 among tracked device types with 412 MAUDE reports spanning 2000–2026. 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

Pliers, Surgical carries 94.7% MALFUNCTION-coded reports, 29.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.6% corpus 30.3% · below corpus mean (-26.7 pp)
  • MALF 94.7% corpus 64.8% · above corpus mean (+29.8 pp)

Lead product-problem code Break is 57% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 52% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Pliers, Surgical in the event-volume neighbourhood

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

reports

What this shows Pliers, Surgical carries 412 MAUDE reports, ranked #957 of 1000.

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

Event Types

Malfunction 390 (94.7%)
Injury 15 (3.6%)
6 (1.5%)
Other 1 (0.2%)

Patient Outcomes

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

373 (91.2%)
Other 20 (4.9%)
Required Intervention 9 (2.2%)
R 3 (0.7%)
Hospitalization 2 (0.5%)
Congenital Anomaly 1 (0.2%)
Disability 1 (0.2%)

Top Product Problems

Break 271
Detachment Of Device Component 23
Detachment of Device or Device Component 20
Component Missing 15
Material Fragmentation 15
Device-Device Incompatibility 14
Device Operates Differently Than Expected 12
Mechanical Problem 12
Fitting Problem 10
Material Integrity Problem 10
Material Twisted/Bent 10
Bent 9
Component Falling 9
Fracture 9
Loose or Intermittent Connection 9
Compatibility Problem 7
Corroded 6
Device Or Device Fragments Location Unknown 5
Difficult to Open or Close 5
Material Discolored 5

Yearly Trend

00
2000: 1
02
2002: 1
06
2006: 1
10
2010: 2
11
2011: 1
12
2012: 3
13
2013: 87
14
2014: 38
15
2015: 31
16
2016: 53
17
2017: 21
18
2018: 16
19
2019: 23
20
2020: 25
21
2021: 18
22
2022: 22
23
2023: 8
24
2024: 25
25
2025: 27
26
2026: 9

Reports rose to 27 in 2025, up from an average of 17 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Pliers, Surgical

Event Locations

235 (57.0%)
I 172 (41.7%)
HOSPITAL 3 (0.7%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
NO INFORMATION 1 (0.2%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable report-volume footprint

Pliers, Surgical 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.

Similar report volume

Nearest other device types by FDA MAUDE report count (412 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pliers, 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 Pliers, 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.