Device brand name · Instrument manual surgical general use
Arthrex: medical device reports filed with FDA
332 reports name it, 1997–2026. Manufacturer given most often on reports: Arthrex. Product code HRX.
- 332
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 28
- reports, 12 months to August 2026
- 22 in the 12 months before
- 75.9%
- classified as malfunction
- 87% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 332 reports that name the brand "Arthrex" (instrument manual surgical general use), received between February 1997 and August 2026; the manufacturer given most often on reports is Arthrex. Spellings of one product vary from report to report.
28 reports arrived in the 12 months to August 2026, up 27% from 22 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (75.9%), injury (19.6%) and other (3%); across all arthroscope reports (product code HRX) death is recorded in 0.1% and malfunction in 87%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (28.3%), detachment of device component (4.2%) and detachment of device or device component (3.9%). The patient problems coded most often are foreign body in patient, device embedded in tissue or plaque and pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 25,683 reports carrying product code HRX. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 94 | 28.3% | 12.5% |
| Detachment of device component | 14 | 4.2% | 1.9% |
| Detachment of device or device componentpart of the device came off | 13 | 3.9% | 2.7% |
| Difficult to removethe device was hard to remove | 9 | 2.7% | 0.4% |
| Difficult to insertthe device was hard to insert | 8 | 2.4% | 0.2% |
| Material fragmentation | 8 | 2.4% | 1.2% |
| Tip breakage | 8 | 2.4% | 2.7% |
| Entrapment of device | 5 | 1.5% | 0.2% |
| Insufficient device problem information | 5 | 1.5% | 0.9% |
| Material separation | 5 | 1.5% | 0.4% |
| Component missing | 4 | 1.2% | 0.7% |
| Device, or device fragments remain in patient | 4 | 1.2% | 1.1% |
| Device, removal of (non-implant) | 4 | 1.2% | 0.5% |
| Failure to sense | 4 | 1.2% | 0% |
| Device or device fragments location unknown | 3 | 0.9% | 0.3% |
| Explanted | 3 | 0.9% | 0% |
| Fracturea broken bone | 3 | 0.9% | 0.6% |
| Compatibility problem | 2 | 0.6% | 0% |
| Component(s), broken | 2 | 0.6% | 0.4% |
| Device contamination with body fluid | 2 | 0.6% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 39 | 11.7% |
| Device embedded in tissue or plaque | 20 | 6% |
| Painpain, site not specified | 7 | 2.1% |
| Foreign body, removal of | 6 | 1.8% |
| Extravasation | 4 | 1.2% |
| Nonresorbable materials, unretrieved in body | 4 | 1.2% |
| Swellingswelling | 4 | 1.2% |
| Surgical procedure, additional | 3 | 0.9% |
| Therapy/non-surgical treatment, additional | 3 | 0.9% |
| Air embolism | 2 | 0.6% |
| Burn(s)a burn | 2 | 0.6% |
| Edemaswelling from fluid | 2 | 0.6% |
| Failure of implant | 2 | 0.6% |
| Hospitalization required | 2 | 0.6% |
| No patient involvement | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Arthrex | Product code HRX | All MAUDE reports |
|---|---|---|---|
| Reports | 332 | 25,683 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 19.6% | 10.6% | 36.2% |
| Classified as malfunction | 75.9% | 87% | 62.3% |
| Filed by the manufacturer | 3.9% | 94.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code HRX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Micro Tornado Hp W Handcontrol | 1,501 | 46 | 0% |
| Dw Arthroscopy Fluid Management Dev | 1,053 | 158 | 0% |
| METRx System | 1,679 | 267 | 0.1% |
| Fms Vue Pump | 706 | 37 | 0% |
| Hd Epscp 4 0 30 167 Mitek | 575 | 27 | 0% |
| 4k C-Mnt Scp 4 0 30 167 Mitek | 541 | 205 | 0% |
| Cordless Driver 3 | 476 | 0 | 0% |
| Dii Controller | 354 | 6 | 0% |
| Shaver Handpiece 2 0 With Buttons | 329 | 87 | 0% |
| 4580 Fms Duo+ Pump/Shaver Combo -Ns | 316 | 2 | 0% |
| Kyphon Xpander Inflatable Bone Tamp | 315 | 22 | 0% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Control Unit Dyonics 25 | 287 | 41 | 0% |
| Fms Tornado Micro Handpiece With Buttons | 285 | 0 | 0% |
| Vapr3 Footswitch Ea | 243 | 2 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Arthrex reports
How many FDA reports name Arthrex?
332 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.
What kinds of events are reported?
malfunction (75.9%), injury (19.6%) and other (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (28.3%), detachment of device component (4.2%), detachment of device or device component (3.9%), difficult to remove (2.7%) and difficult to insert (2.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
voluntary reports (35.2%) and manufacturer reports (3.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Arthrex was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.