Device manufacturer, as written on reports
Stryker Instruments-A Division Of Stryker: medical device reports filed with FDA
13,787 reports name it as the manufacturer of the device involved, 2019–2026.
- 13,787
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 1,522
- reports, 12 months to August 2026
- 2,378 in the 12 months before
- 97.2%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
13,787 medical device reports received by FDA give Stryker Instruments-A Division Of Stryker as the manufacturer of the device involved, 0.1% of the MAUDE database, from January 2019 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
1,522 reports arrived in the 12 months to August 2026, down 36% from 2,378 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 (97.2%) and injury (2.8%). 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 |
|---|---|---|---|---|
| Unknown_InstrumentstIre_Product | Drills, burrs, trephines & accessories (simple, powered) | 709 | 123 | 0% |
| Remb Electric Sagittal Saw | Drill, surgical, ent (electric or pneumatic) including handpiece | 671 | 4 | 0% |
| S2 Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 537 | 79 | 0% |
| Smartlife Large Aspetic Housing | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 395 | 2 | 0% |
| Remb Electric Micro Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 307 | 9 | 0% |
| Tpx Sagittal Saw | Drill, surgical, ent (electric or pneumatic) including handpiece | 306 | 83 | 0% |
| Straight Irrigating Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 297 | 34 | 0% |
| Tpx Micro Drill | Drill, surgical, ent (electric or pneumatic) including handpiece | 255 | 106 | 0% |
| Remb Electric Oscillating Saw | Drill, surgical, ent (electric or pneumatic) including handpiece | 209 | 0 | 0% |
| Angled Irrigating Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 137 | 17 | 0% |
| Straight Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 131 | 20 | 0% |
| Unknown Instruments Product | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 130 | 23 | 0.8% |
| Pi Drive Plus Motor | Drill, surgical, ent (electric or pneumatic) including handpiece | 116 | 0 | 0% |
| Elite 7cm Straight Attachment | Drills, burrs, trephines & accessories (simple, powered) | 111 | 17 | 0% |
| Neptune 3 Rover 120v | Apparatus, suction, ward use, portable, ac-powered | 106 | 0 | 1.1% |
| Remb Electric Reciprocating Saw | Drill, surgical, ent (electric or pneumatic) including handpiece | 105 | 2 | 0% |
| Footed Attachment 16mm | Drills, burrs, trephines & accessories (simple, powered) | 92 | 18 | 0% |
| 2.3mm Tapered Router | Drills, burrs, trephines & accessories (simple, powered) | 90 | 10 | 0% |
| Elite 12cm Angled Attachment | Drills, burrs, trephines & accessories (simple, powered) | 87 | 16 | 0% |
| Pi Drive Motor | Drill, surgical, ent (electric or pneumatic) including handpiece | 84 | 0 | 0% |
| Elite 12cm Straight Attachment | Drills, burrs, trephines & accessories (simple, powered) | 60 | 12 | 0% |
| MIS 13cm Curved Attachment | Drills, burrs, trephines & accessories (simple, powered) | 58 | 11 | 0% |
| Smartlife Small Asptc Housing | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 56 | 0 | 0% |
| Sumex | Drill, surgical, ent (electric or pneumatic) including handpiece | 53 | 0 | 0% |
| Elite 14cm Angled Attachment | Drills, burrs, trephines & accessories (simple, powered) | 50 | 17 | 0% |
| Push-Button Smoke Evac Pencil Coated | Electrosurgical, cutting & coagulation & accessories | 48 | 12 | 0% |
| Electric Handswitch- Right Handed | Drill, surgical, ent (electric or pneumatic) including handpiece | 36 | 1 | 0% |
| Sd/Pd Series Long Angled Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 29 | 2 | 0% |
| Sd/Pd Series Long Straight Attachment | Drill, surgical, ent (electric or pneumatic) including handpiece | 19 | 6 | 0% |
| Pin Collet 2 0-3 2mm | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 18 | 4 | 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 |
|---|---|---|---|
| ERL | Drill, surgical, ent (electric or pneumatic) including handpiece | 4,786 | 34.7% |
| HBE | Drills, burrs, trephines & accessories (simple, powered) | 2,641 | 19.2% |
| HWE | Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment | 2,325 | 16.9% |
| GFA | Blade, saw, general & plastic surgery, surgical | 841 | 6.1% |
| GEI | Electrosurgical, cutting & coagulation & accessories | 377 | 2.7% |
| LFL | Instrument, ultrasonic surgical | 226 | 1.6% |
| HAW | Neurological stereotaxic instrument | 218 | 1.6% |
| HBB | Motor, drill, pneumatic | 206 | 1.5% |
| EIA | Unit, operative dental | 168 | 1.2% |
| KCY | Tourniquet, pneumatic | 168 | 1.2% |
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 Stryker Instruments-A Division Of Stryker reports
How many FDA device reports name Stryker Instruments-A Division Of Stryker as manufacturer?
13,787 reports through August 2026, 1,522 of them in the latest 12 months.
Which of its brands appear most often?
Unknown_InstrumentstIre_Product (709), Remb Electric Sagittal Saw (671), S2 Drill (537), Smartlife Large Aspetic Housing (395) and Remb Electric Micro Drill (307).
Which device types does it report on?
drill, surgical, ent (electric or pneumatic) including handpiece (34.7%), drills, burrs, trephines & accessories (simple, powered) (19.2%), instrument, surgical, orthopedic, ac-powered motor and accessory/attachment (16.9%) and blade, saw, general & plastic surgery, surgical (6.1%).
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.