2026 data FDA MAUDE openFDA FDA Class I

Hammer, 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 Hammer, Surgical LIGHT-BOOK · MAUDE

#708 of 1000 · 858 reports · 1998–2026

  • BOOK 858 reports
  • RANK #708 of 1000
  • DEATH 0 death-typed
  • INJ 39 injury-typed
  • MALF 819 malfunction
  • SPAN 1998–2026
  • PEAK 2017: 92
  • PHOTO Heat-Exchanger

Nearest event-volume peer: Heat-Exchanger, Cardiopulmonary Bypass (0 report gap)

Hammer, Surgical sits #708 of 1000 among tracked device types with 858 MAUDE reports spanning 1998–2026. 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

Hammer, Surgical carries 95.5% MALFUNCTION-coded reports, 30.6pp 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 4.5% corpus 30.3% · below corpus mean (-25.7 pp)
  • MALF 95.5% corpus 64.8% · above corpus mean (+30.6 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 32% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .

Hammer, Surgical in the event-volume neighbourhood

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

reports

What this shows Hammer, Surgical carries 858 MAUDE reports, ranked #708 of 1000.

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

Event Types

Malfunction 819 (95.5%)
Injury 39 (4.5%)

Patient Outcomes

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

809 (94.2%)
Required Intervention 34 (4.0%)
Hospitalization 7 (0.8%)
R 5 (0.6%)
Other 4 (0.5%)

Top Product Problems

Break 394
Device-Device Incompatibility 127
Material Twisted/Bent 71
Naturally Worn 61
Material Deformation 51
Contamination /Decontamination Problem 43
Device Contamination with Chemical or Other Material 43
Residue After Decontamination 30
Leak/Splash 23
Appropriate Device Problem Term/Code Not Available 19
Fracture 17
Material Integrity Problem 12
Device Operates Differently Than Expected 11
Mechanical Jam 11
Crack 10
Disassembly 9
Detachment Of Device Component 7
Scratched Material 7
Adverse Event Without Identified Device or Use Problem 6
Connection Problem 6

Yearly Trend

98
1998: 2
00
2000: 1
01
2001: 1
09
2009: 2
11
2011: 1
12
2012: 1
13
2013: 56
14
2014: 23
15
2015: 20
16
2016: 45
17
2017: 92
18
2018: 72
19
2019: 75
20
2020: 79
21
2021: 69
22
2022: 68
23
2023: 79
24
2024: 83
25
2025: 53
26
2026: 36

Reports in 2025 (53) held close to the prior two-year average of 81.

Related Entities for Hammer, Surgical

Compare SYNTHES GMBH vs DEPUY ORTHOPAEDICS INC US →

Nationwide devices with a comparable report-volume footprint

Hammer, 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 (858 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 Hammer, 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 Hammer, 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.