Reported Reactions

Manufacturers

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

BrandDevice typeReportsLatest 12 monthsClassified as death
Unknown_InstrumentstIre_ProductDrills, burrs, trephines & accessories (simple, powered)7091230%
Remb Electric Sagittal SawDrill, surgical, ent (electric or pneumatic) including handpiece67140%
S2 DrillDrill, surgical, ent (electric or pneumatic) including handpiece537790%
Smartlife Large Aspetic HousingInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment39520%
Remb Electric Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece30790%
Tpx Sagittal SawDrill, surgical, ent (electric or pneumatic) including handpiece306830%
Straight Irrigating AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece297340%
Tpx Micro DrillDrill, surgical, ent (electric or pneumatic) including handpiece2551060%
Remb Electric Oscillating SawDrill, surgical, ent (electric or pneumatic) including handpiece20900%
Angled Irrigating AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece137170%
Straight AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece131200%
Unknown Instruments ProductInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment130230.8%
Pi Drive Plus MotorDrill, surgical, ent (electric or pneumatic) including handpiece11600%
Elite 7cm Straight AttachmentDrills, burrs, trephines & accessories (simple, powered)111170%
Neptune 3 Rover 120vApparatus, suction, ward use, portable, ac-powered10601.1%
Remb Electric Reciprocating SawDrill, surgical, ent (electric or pneumatic) including handpiece10520%
Footed Attachment 16mmDrills, burrs, trephines & accessories (simple, powered)92180%
2.3mm Tapered RouterDrills, burrs, trephines & accessories (simple, powered)90100%
Elite 12cm Angled AttachmentDrills, burrs, trephines & accessories (simple, powered)87160%
Pi Drive MotorDrill, surgical, ent (electric or pneumatic) including handpiece8400%
Elite 12cm Straight AttachmentDrills, burrs, trephines & accessories (simple, powered)60120%
MIS 13cm Curved AttachmentDrills, burrs, trephines & accessories (simple, powered)58110%
Smartlife Small Asptc HousingInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment5600%
SumexDrill, surgical, ent (electric or pneumatic) including handpiece5300%
Elite 14cm Angled AttachmentDrills, burrs, trephines & accessories (simple, powered)50170%
Push-Button Smoke Evac Pencil CoatedElectrosurgical, cutting & coagulation & accessories48120%
Electric Handswitch- Right HandedDrill, surgical, ent (electric or pneumatic) including handpiece3610%
Sd/Pd Series Long Angled AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece2920%
Sd/Pd Series Long Straight AttachmentDrill, surgical, ent (electric or pneumatic) including handpiece1960%
Pin Collet 2 0-3 2mmInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment1840%

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 codeDevice typeReportsShare
ERLDrill, surgical, ent (electric or pneumatic) including handpiece4,78634.7%
HBEDrills, burrs, trephines & accessories (simple, powered)2,64119.2%
HWEInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment2,32516.9%
GFABlade, saw, general & plastic surgery, surgical8416.1%
GEIElectrosurgical, cutting & coagulation & accessories3772.7%
LFLInstrument, ultrasonic surgical2261.6%
HAWNeurological stereotaxic instrument2181.6%
HBBMotor, drill, pneumatic2061.5%
EIAUnit, operative dental1681.2%
KCYTourniquet, pneumatic1681.2%

Reports by month, five years

0304608Sep 2021: 135Oct 2021: 314Nov 2021: 174Dec 2021: 1402022Jan 2022: 265Feb 2022: 130Mar 2022: 169Apr 2022: 323May 2022: 122Jun 2022: 148Jul 2022: 317Aug 2022: 155Sep 2022: 122Oct 2022: 364Nov 2022: 153Dec 2022: 1652023Jan 2023: 303Feb 2023: 147Mar 2023: 195Apr 2023: 608May 2023: 145Jun 2023: 201Jul 2023: 336Aug 2023: 181Sep 2023: 113Oct 2023: 383Nov 2023: 105Dec 2023: 1272024Jan 2024: 326Feb 2024: 113Mar 2024: 155Apr 2024: 391May 2024: 120Jun 2024: 120Jul 2024: 419Aug 2024: 116Sep 2024: 105Oct 2024: 429Nov 2024: 74Dec 2024: 852025Jan 2025: 376Feb 2025: 108Mar 2025: 97Apr 2025: 385May 2025: 96Jun 2025: 131Jul 2025: 403Aug 2025: 89Sep 2025: 69Oct 2025: 362Nov 2025: 108Dec 2025: 742026Jan 2026: 239Feb 2026: 83Mar 2026: 64Apr 2026: 221May 2026: 131Jun 2026: 20Jul 2026: 133Aug 2026: 18

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0%5
Injury2.8%383
Malfunction97.2%13,399
Other0%0
Not given0%0

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.