2026 data FDA MAUDE openFDA FDA Class I

Screwdriver

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 Screwdriver MID-BOOK · MAUDE

#131 of 1000 · 23,256 reports · 1994–2026

  • BOOK 23,256 reports
  • RANK #131 of 1000
  • DEATH 4 death-typed
  • INJ 1,567 injury-typed
  • MALF 21,544 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 2,151
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (8 report gap)

Screwdriver sits #131 of 1000 among tracked device types with 23,256 MAUDE reports spanning 1994–2026. 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

Screwdriver carries 92.6% MALFUNCTION-coded reports, 27.8pp 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 6.7% corpus 30.3% · below corpus mean (-23.6 pp)
  • MALF 92.6% corpus 64.8% · above corpus mean (+27.8 pp)

Lead product-problem code Break is 45% of coded problems · Lead manufacturer SYNTHES GMBH accounts for 30% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Screwdriver in the event-volume neighbourhood

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

reports

What this shows Screwdriver carries 23,256 MAUDE reports, ranked #131 of 1000.

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

Event Types

Malfunction 21,544 (92.6%)
Injury 1,567 (6.7%)
Other 82 (0.4%)
58 (0.2%)
Death 4 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

20,255 (87.8%)
Other 1,458 (6.3%)
Required Intervention 1,045 (4.5%)
Hospitalization 125 (0.5%)
R 108 (0.5%)
Disability 21 (0.1%)
O 18 (0.1%)
S 14 (0.1%)
H 7 (0.0%)
Death 4 (0.0%)
Congenital Anomaly 3 (0.0%)
L 1 (0.0%)
Life Threatening 1 (0.0%)

Top Product Problems

Break 10,871
Material Twisted/Bent 3,671
Device-Device Incompatibility 2,002
Fracture 1,622
Material Deformation 1,151
Naturally Worn 780
Detachment Of Device Component 497
Tip breakage 433
Bent 341
Material Integrity Problem 335
Material Fragmentation 301
Calibration Problem 283
Device Operates Differently Than Expected 279
Dull, Blunt 271
Contamination /Decontamination Problem 264
Detachment of Device or Device Component 258
Appropriate Device Problem Term/Code Not Available 252
Difficult to Remove 245
Crack 211
Entrapment of Device 206

Yearly Trend

94
1994: 9
95
1995: 7
96
1996: 27
97
1997: 69
98
1998: 79
99
1999: 21
00
2000: 14
01
2001: 46
02
2002: 71
03
2003: 51
04
2004: 28
05
2005: 55
06
2006: 55
07
2007: 167
08
2008: 450
09
2009: 488
10
2010: 374
11
2011: 234
12
2012: 293
13
2013: 1,173
14
2014: 793
15
2015: 882
16
2016: 990
17
2017: 1,369
18
2018: 1,469
19
2019: 2,012
20
2020: 1,644
21
2021: 2,001
22
2022: 1,721
23
2023: 1,733
24
2024: 1,708
25
2025: 2,151
26
2026: 1,072

Reports in 2025 (2,151) held close to the prior two-year average of 1,721.

Related Entities for Screwdriver

Event Locations

12,912 (55.5%)
I 9,238 (39.7%)
HOSPITAL 1,006 (4.3%)
NO INFORMATION 52 (0.2%)
INVALID DATA 12 (0.1%)
OTHER 12 (0.1%)
AMBULATORY SURGICAL FACILITY 8 (0.0%)
UNKNOWN 8 (0.0%)
NOT APPLICABLE 4 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare SYNTHES GMBH vs WRIGHTS LANE SYNTHES USA PRODUCTS LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Screwdriver: 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 (23,256 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Disclaimer: MAUDE figures for Screwdriver 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 Screwdriver; 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.