2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Bit, Drill MID-BOOK · MAUDE

#151 of 1000 · 16,997 reports · 1992–2026

  • BOOK 16,997 reports
  • RANK #151 of 1000
  • DEATH 5 death-typed
  • INJ 2,383 injury-typed
  • MALF 14,360 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 1,772
  • PHOTO Console

Nearest event-volume peer: Console, Heart-Lung Machine, Cardiopulmonary Bypass (264 report gap)

Bit, Drill sits #151 of 1000 among tracked device types with 16,997 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 →

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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 14.0% corpus 30.4% · below corpus mean (-16.4 pp)
  • MALF 84.5% corpus 64.5% · above corpus mean (+20.0 pp)

Lead product-problem code Break is 53% of coded problems · Lead manufacturer DEPUY ORTHOPAEDICS INC US accounts for 42% of manufacturer-tagged reports · Top event location is 54% 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 16,997 MAUDE reports, ranked #151 of 1000.

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

Event Types

Malfunction 14,360 (84.5%)
Injury 2,383 (14.0%)
Other 179 (1.1%)
70 (0.4%)
Death 5 (0.0%)

Patient Outcomes

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

13,613 (79.3%)
Other 1,582 (9.2%)
Required Intervention 1,532 (8.9%)
Hospitalization 164 (1.0%)
R 127 (0.7%)
Disability 57 (0.3%)
S 35 (0.2%)
O 22 (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 7,914
Failure to Cut 1,181
Fracture 1,045
Entrapment of Device 951
Device-Device Incompatibility 749
Material Deformation 716
Material Twisted/Bent 470
Dull, Blunt 355
Naturally Worn 269
Material Fragmentation 258
Bent 224
Mechanical Jam 117
Material Integrity Problem 102
Device Operates Differently Than Expected 94
Appropriate Term/Code Not Available 92
Contamination /Decontamination Problem 71
No Apparent Adverse Event 70
Corroded 69
Physical Resistance/Sticking 65
Adverse Event Without Identified Device or Use Problem 60

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: 229

Related Entities for Bit, Drill

Event Locations

9,199 (54.1%)
I 6,362 (37.4%)
HOSPITAL 1,210 (7.1%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Bit, Drill, 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 (16,997 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 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.