Device manufacturer, as written on reports
Depuy Mitek US: medical device reports filed with FDA
24,966 reports name it as the manufacturer of the device involved, 2013–2026.
- 24,966
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 3,081
- reports, 12 months to August 2026
- 2,648 in the 12 months before
- 91.3%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
24,966 medical device reports received by FDA give Depuy Mitek US as the manufacturer of the device involved, 0.1% of the MAUDE database, from May 2013 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
3,081 reports arrived in the 12 months to August 2026, up 16% from 2,648 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 (91.3%) and injury (8.7%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."
Brands named most often
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Micro Tornado Hp W Handcontrol | Arthroscope | 1,453 | 46 | 0% |
| UNK - Implant | Fastener, fixation, biodegradable, soft tissue | 759 | 80 | 0% |
| Vapr Tripolar 90 Suction Elect | Electrosurgical, cutting & coagulation & accessories | 720 | 118 | 0% |
| Omnispan Meniscal Repair 27deg | Fastener, fixation, biodegradable, soft tissue | 670 | 161 | 0% |
| Fms Vue Pump | Arthroscope | 631 | 37 | 0% |
| Vapr Vue Generator | Electrosurgical, cutting & coagulation & accessories | 622 | 44 | 0% |
| Gryphon P Br Ds Anchor W/Oc | Fastener, fixation, biodegradable, soft tissue | 544 | 111 | 0% |
| 4 75 Healix Advance Kntlss Br | Fastener, fixation, biodegradable, soft tissue | 466 | 71 | 0% |
| 4 5 Healix Advance Br W/Ocord | Fastener, fixation, biodegradable, soft tissue | 431 | 140 | 0% |
| Omnispan Meniscal Repair 12deg | Fastener, fixation, biodegradable, soft tissue | 415 | 44 | 0% |
| Vapr Coolpulse90 Electrode | Electrosurgical, cutting & coagulation & accessories | 414 | 36 | 0% |
| Vapr S90 4 0mm W/Integr Hdp -Ea | Electrosurgical, cutting & coagulation & accessories | 316 | 50 | 0% |
| Fms Tornado Micro Handpiece With Buttons | Arthroscope | 285 | 0 | 0% |
| 4580 Fms Duo+ Pump/Shaver Combo -Ns | Arthroscope | 277 | 2 | 0% |
| Lupine Br Ds W/Orthcrd | Fastener, fixation, biodegradable, soft tissue | 274 | 44 | 0% |
| Meniscal Deployment Gun | Applier, staple, surgical, | 233 | 69 | 0% |
| Cordcutter Ea | Cutter, surgical | 228 | 24 | 0% |
| Arthro Pusher/Cutter Ea | Accessories, arthroscopic | 215 | 48 | 0% |
| 4 5 Healix Advance Br3sut W/Oc | Fastener, fixation, biodegradable, soft tissue | 212 | 12 | 0% |
| Vapr Clplse90 Electrode W Hand Cntrls | Electrosurgical, cutting & coagulation & accessories | 209 | 66 | 0% |
| Omnispan Orthocord | Fastener, fixation, nondegradable, soft tissue | 197 | 201 | 0% |
| Vapr | Electrosurgical, cutting & coagulation & accessories | 192 | 193 | 0% |
| Vapr3 Footswitch Ea | Arthroscope | 189 | 2 | 0% |
| Healix Advance Orthocord | Fastener, fixation, biodegradable, soft tissue | 188 | 188 | 0% |
| 8022 Handpc Tornado Shaver | Arthroscope | 176 | 0 | 0% |
| Vapr Vue Wireless Footswitch | Electrosurgical, cutting & coagulation & accessories | 165 | 8 | 0% |
| Omnispan Meniscal Repair System/27 Degree | Fastener, fixation, biodegradable, soft tissue | 143 | 0 | 0% |
| Vapr Tripolar90 Suction Electrode | Electrosurgical, cutting & coagulation & accessories | 137 | 0 | 0% |
| Inflow Tubing Fms Vue 24pk | Arthroscope | 125 | 22 | 0% |
| Vapr Premiere 90 Electrode -Ea | Electrosurgical, cutting & coagulation & accessories | 110 | 14 | 0% |
Brands with a page on this site, 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."
Device types
| Product code | Device type | Reports | Share |
|---|---|---|---|
| MAI | Fastener, fixation, biodegradable, soft tissue | 7,017 | 28.1% |
| HRX | Arthroscope | 5,245 | 21% |
| GEI | Electrosurgical, cutting & coagulation & accessories | 3,935 | 15.8% |
| LXH | Orthopedic manual surgical instrument | 2,881 | 11.5% |
| HWC | Screw, fixation, bone | 1,491 | 6% |
| MBI | Fastener, fixation, nondegradable, soft tissue | 876 | 3.5% |
| NBH | Accessories, arthroscopic | 864 | 3.5% |
| FZT | Cutter, surgical | 358 | 1.4% |
| JDR | Staple, fixation, bone | 350 | 1.4% |
| GEF | Applier, staple, surgical, | 247 | 1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type
Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Questions about Depuy Mitek US reports
How many FDA device reports name Depuy Mitek US as manufacturer?
24,966 reports through August 2026, 3,081 of them in the latest 12 months.
Which of its brands appear most often?
Micro Tornado Hp W Handcontrol (1,453), UNK - Implant (759), Vapr Tripolar 90 Suction Elect (720), Omnispan Meniscal Repair 27deg (670) and Fms Vue Pump (631).
Which device types does it report on?
fastener, fixation, biodegradable, soft tissue (28.1%), arthroscope (21%), electrosurgical, cutting & coagulation & accessories (15.8%) and orthopedic manual surgical instrument (11.5%).
Does a high count say something about the manufacturer?
Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."
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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.