2026 data FDA MAUDE openFDA FDA Class I

Reamer

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 §888.4540 (Orthopedic panel).

FDA MAUDE casebook

openFDA event book Reamer MID-BOOK · MAUDE

#110 of 1000 · 29,419 reports · 1992–2026

  • BOOK 29,419 reports
  • RANK #110 of 1000
  • DEATH 5 death-typed
  • INJ 1,217 injury-typed
  • MALF 28,156 malfunction
  • SPAN 1992–2026
  • PEAK 2021: 4,802
  • PHOTO Drill

Nearest event-volume peer: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (364 report gap)

Reamer sits #110 of 1000 among tracked device types with 29,419 MAUDE reports spanning 1992–2026. 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

Reamer carries 95.7% MALFUNCTION-coded reports, 30.9pp 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 4.1% corpus 30.3% · below corpus mean (-26.2 pp)
  • MALF 95.7% corpus 64.8% · above corpus mean (+30.9 pp)

Lead product-problem code Failure to Cut is 45% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 75% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Reamer in the event-volume neighbourhood

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

reports

What this shows Reamer carries 29,419 MAUDE reports, ranked #110 of 1000.

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

Event Types

Malfunction 28,156 (95.7%)
Injury 1,217 (4.1%)
Other 29 (0.1%)
12 (0.0%)
Death 5 (0.0%)

Patient Outcomes

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

27,795 (94.3%)
Required Intervention 1,106 (3.8%)
Other 386 (1.3%)
Hospitalization 80 (0.3%)
R 73 (0.2%)
Disability 8 (0.0%)
S 6 (0.0%)
Death 6 (0.0%)
H 4 (0.0%)
O 3 (0.0%)
Invalid Data 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Failure to Cut 15,103
Break 4,000
Dull, Blunt 3,752
Naturally Worn 2,295
Corroded 2,049
No Apparent Adverse Event 1,064
Device-Device Incompatibility 925
Material Twisted/Bent 721
Adverse Event Without Identified Device or Use Problem 596
Material Deformation 586
Entrapment of Device 452
Appropriate Device Problem Term/Code Not Available 334
Illegible Information 309
Fracture 299
Crack 231
Detachment Of Device Component 195
Contamination /Decontamination Problem 191
Material Fragmentation 166
Material Discolored 153
Detachment of Device or Device Component 134

Yearly Trend

92
1992: 2
93
1993: 1
94
1994: 4
95
1995: 6
96
1996: 12
97
1997: 17
98
1998: 15
99
1999: 4
00
2000: 8
01
2001: 18
02
2002: 32
03
2003: 31
04
2004: 24
05
2005: 20
06
2006: 38
07
2007: 31
08
2008: 76
09
2009: 81
10
2010: 90
11
2011: 79
12
2012: 162
13
2013: 523
14
2014: 405
15
2015: 655
16
2016: 1,039
17
2017: 1,234
18
2018: 1,835
19
2019: 1,954
20
2020: 1,531
21
2021: 4,802
22
2022: 3,909
23
2023: 4,401
24
2024: 4,746
25
2025: 1,056
26
2026: 578

Reports fell to 1,056 in 2025, down from an average of 4,574 in the two years before.

Related Entities for Reamer

Event Locations

18,238 (62.0%)
I 10,879 (37.0%)
HOSPITAL 231 (0.8%)
NO INFORMATION 51 (0.2%)
INVALID DATA 8 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (0.0%)
UNKNOWN 4 (0.0%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OTHER 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare DEPUY ORTHOPAEDICS INC US vs SYNTHES GMBH →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Reamer: 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 (29,419 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Disclaimer: MAUDE figures for Reamer 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 Reamer; 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.