PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Passer

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).

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FDA MAUDE casebook

openFDA event book Passer LIGHT-BOOK · MAUDE

#690 of 1000 · 906 reports · 1995–2026

  • BOOK 906 reports
  • RANK #690 of 1000
  • DEATH 0 death-typed
  • INJ 189 injury-typed
  • MALF 708 malfunction
  • SPAN 1995–2026
  • PEAK 2020: 171
  • PHOTO Enzyme Immunoassay

Nearest event-volume peer: Enzyme Immunoassay, Diphenylhydantoin (1 report gap)

Passer sits #690 of 1000 among tracked device types with 906 MAUDE reports spanning 1995–2026. 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

Passer carries 78.1% MALFUNCTION-coded reports, 13.3pp 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 20.9% corpus 30.3% · below corpus mean (-9.4 pp)
  • MALF 78.1% corpus 64.8% · above corpus mean (+13.3 pp)

Lead product-problem code Break is 51% of coded problems · Lead manufacturer SMITH & NEPHEW, INC. accounts for 35% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Passer in the event-volume neighbourhood

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

reports

What this shows Passer carries 906 MAUDE reports, ranked #690 of 1000.

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

Event Types

Malfunction 708 (78.1%)
Injury 189 (20.9%)
Other 8 (0.9%)
1 (0.1%)

Patient Outcomes

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

665 (71.7%)
Required Intervention 141 (15.2%)
Other 87 (9.4%)
R 17 (1.8%)
Hospitalization 7 (0.8%)
O 5 (0.5%)
H 2 (0.2%)
L 1 (0.1%)
S 1 (0.1%)
Congenital Anomaly 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Break 460
Detachment of Device or Device Component 75
Material Separation 55
Mechanical Jam 40
Material Fragmentation 29
Tip breakage 28
Detachment Of Device Component 25
Fracture 21
Mechanical Problem 21
Failure to Advance 20
Device Operates Differently Than Expected 18
Adverse Event Without Identified Device or Use Problem 16
Material Deformation 14
Material Integrity Problem 14
Physical Resistance/Sticking 14
Device, or device fragments remain in patient 13
Insufficient Device Problem Information 11
Difficult to Open or Close 10
Out-Of-Box Failure 9
Component Falling 8

Yearly Trend

95
1995: 1
96
1996: 1
97
1997: 3
98
1998: 4
99
1999: 1
00
2000: 2
01
2001: 3
02
2002: 1
03
2003: 1
04
2004: 4
05
2005: 2
06
2006: 10
07
2007: 7
08
2008: 7
09
2009: 3
10
2010: 2
11
2011: 30
12
2012: 9
13
2013: 9
14
2014: 10
15
2015: 14
16
2016: 28
17
2017: 39
18
2018: 64
19
2019: 55
20
2020: 171
21
2021: 160
22
2022: 63
23
2023: 60
24
2024: 50
25
2025: 68
26
2026: 24

Reports in 2025 (68) held close to the prior two-year average of 55.

Related Entities for Passer

Top Manufacturers

SMITH & NEPHEW, INC. 262
ARTHROCARE CORP. 196
ARTHROCARE CORPORATION 157
STRYKER ENDOSCOPY-SAN JOSE 50
ZIMMER BIOMET, INC. 41
OBERDORF SYNTHES PRODUKTIONS GMBH 17
DEPUY MITEK 16

Event Locations

I 448 (49.4%)
386 (42.6%)
HOSPITAL 52 (5.7%)
NO INFORMATION 9 (1.0%)
AMBULATORY SURGICAL FACILITY 6 (0.7%)
OTHER 3 (0.3%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare SMITH & NEPHEW, INC. vs ARTHROCARE CORP. →

Nationwide devices with a comparable report-volume footprint

Passer 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 (906 here).

Enzyme Immunoassay, Diphenylhydantoin 905 Device 909 Implant, Fixation Device, Spinal 909 Appliance 910

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Passer 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 Passer; 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.