2026 data FDA MAUDE openFDA FDA Class I

Bit, Drill

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 Bit, Drill MID-BOOK · MAUDE

#154 of 1000 · 17,754 reports · 1992–2026

  • BOOK 17,754 reports
  • RANK #154 of 1000
  • DEATH 5 death-typed
  • INJ 2,407 injury-typed
  • MALF 15,093 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 1,772
  • PHOTO Implant

Nearest event-volume peer: Implant, Intragastric For Morbid Obesity (91 report gap)

Bit, Drill sits #154 of 1000 among tracked device types with 17,754 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

Bit, Drill carries 85.0% MALFUNCTION-coded reports, 20.2pp 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 13.6% corpus 30.3% · below corpus mean (-16.7 pp)
  • MALF 85.0% corpus 64.8% · above corpus mean (+20.2 pp)

Lead product-problem code Break is 54% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 42% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Bit, Drill in the event-volume neighbourhood

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

reports

What this shows Bit, Drill carries 17,754 MAUDE reports, ranked #154 of 1000.

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

Event Types

Malfunction 15,093 (85.0%)
Injury 2,407 (13.6%)
Other 179 (1.0%)
70 (0.4%)
Death 5 (0.0%)

Patient Outcomes

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

14,197 (79.9%)
Other 1,600 (9.0%)
Required Intervention 1,538 (8.7%)
Hospitalization 164 (0.9%)
R 127 (0.7%)
Disability 58 (0.3%)
S 35 (0.2%)
O 24 (0.1%)
Death 7 (0.0%)
H 6 (0.0%)
Invalid Data 5 (0.0%)
Life Threatening 3 (0.0%)
L 2 (0.0%)
Congenital Anomaly 2 (0.0%)
D 1 (0.0%)

Top Product Problems

Break 10,301
Fracture 1,374
Failure to Cut 1,247
Entrapment of Device 1,056
Material Deformation 784
Device-Device Incompatibility 781
Material Twisted/Bent 481
Device, or device fragments remain in patient 403
Dull, Blunt 373
Material Fragmentation 368
Detachment Of Device Component 365
Bent 278
Naturally Worn 273
Tip breakage 253
Difficult to Remove 197
Device Operates Differently Than Expected 179
Mechanical Jam 157
Unknown (for use when the device problem is not known) 138
Material Integrity Problem 116
Detachment of Device or Device Component 112

Yearly Trend

92
1992: 14
93
1993: 9
94
1994: 20
95
1995: 22
96
1996: 44
97
1997: 95
98
1998: 73
99
1999: 53
00
2000: 66
01
2001: 49
02
2002: 65
03
2003: 46
04
2004: 69
05
2005: 83
06
2006: 133
07
2007: 146
08
2008: 216
09
2009: 256
10
2010: 270
11
2011: 225
12
2012: 256
13
2013: 519
14
2014: 409
15
2015: 400
16
2016: 595
17
2017: 1,129
18
2018: 1,240
19
2019: 1,212
20
2020: 1,245
21
2021: 1,569
22
2022: 1,519
23
2023: 1,772
24
2024: 1,422
25
2025: 1,527
26
2026: 986

Reports in 2025 (1,527) held close to the prior two-year average of 1,597.

Related Entities for Bit, Drill

Event Locations

9,955 (56.1%)
I 6,362 (35.8%)
HOSPITAL 1,211 (6.8%)
NO INFORMATION 135 (0.8%)
INVALID DATA 34 (0.2%)
AMBULATORY SURGICAL FACILITY 20 (0.1%)
OTHER 13 (0.1%)
UNKNOWN 13 (0.1%)
OUTPATIENT TREATMENT FACILITY 9 (0.1%)
HOME 1 (0.0%)
NOT APPLICABLE 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 Bit, Drill: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Disclaimer: MAUDE figures for Bit, Drill 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 Bit, Drill; 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.