ARTHREX, INC.

FDA MAUDE device safety record · 1993–2026

What the Data Shows About ARTHREX, INC.

ARTHREX, INC. is associated with 29,336 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 2 are coded as death reports and 7,116 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for ARTHREX, INC. should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 21,539 reports (73.4% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 33 years of MAUDE data, with the peak single-year volume reaching 9,228 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

29,336
Total Reports
2
Death Reports
7,116
Injury Reports
20
Device Types

Event Types

Malfunction 21,539 (73.4%)
Injury 7,116 (24.3%)
Other 659 (2.2%)
20 (0.1%)
Death 2 (0.0%)

Patient Outcomes

21,274 (72.0%)
Other 7,466 (25.3%)
Required Intervention 412 (1.4%)
R 224 (0.8%)
Hospitalization 69 (0.2%)
O 55 (0.2%)
H 22 (0.1%)
Disability 12 (0.0%)
Death 8 (0.0%)
S 4 (0.0%)
Congenital Anomaly 2 (0.0%)
Life Threatening 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 2
96
1996: 2
97
1997: 2
98
1998: 5
99
1999: 4
00
2000: 5
01
2001: 2
02
2002: 3
03
2003: 5
04
2004: 170
05
2005: 266
06
2006: 217
07
2007: 270
08
2008: 253
09
2009: 239
10
2010: 275
11
2011: 255
12
2012: 296
13
2013: 302
14
2014: 291
15
2015: 221
16
2016: 21
17
2017: 26
18
2018: 349
19
2019: 783
20
2020: 937
21
2021: 1,791
22
2022: 1,823
23
2023: 3,840
24
2024: 9,228
25
2025: 6,356
26
2026: 1,096

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.