Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Depuy Synthes Products: medical device reports filed with FDA

24,793 reports name it as the manufacturer of the device involved, 2017–2026.

24,793
reports naming it as manufacturer
0.1% of all MAUDE reports
264
reports, 12 months to August 2026
839 in the 12 months before
99.4%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

24,793 medical device reports received by FDA give Depuy Synthes Products as the manufacturer of the device involved, 0.1% of the MAUDE database, from October 2017 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

264 reports arrived in the 12 months to August 2026, down 69% from 839 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 (99.4%) and injury (0.6%). 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
Emax 2 Plus MotorMotor, drill, electric3,405620%
High Speed Elec G1 Handpiece Air CooledMotor, drill, electric1,073250.1%
6 5cm Adult Crani AttachmtMotor, drill, electric1,039410%
Battery Handpiece/Modular For TrsMotor, surgical instrument, ac-powered9652130%
Motor Assembly XmaxDrill, surgical, ent (electric or pneumatic) including handpiece883140%
11cm Angle AttachmentMotor, drill, electric77830%
Xmax MotorDrill, surgical, ent (electric or pneumatic) including handpiece71300%
Small Battery DriveInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment59500%
8cm Angle AttachmentMotor, drill, electric51660%
5 0 Cm Short AttachmentMotor, drill, electric45190%
Electric Pen Drive 60 000 RpmInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment441940%
Adult CraniotomeMotor, drill, electric43690.2%
11 Cm Medium Qd Angle AttachmentMotor, drill, electric385100%
Air Pen DriveMotor, drill, pneumatic382220%
Kincise Automated Surgical ImpactorMotor, surgical instrument, ac-powered357110%
Air OscillatorInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment33900%
Sagittal Saw AttachmentInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment238640%
Compact Speed Reducer 60 1Drills, burrs, trephines & accessories (simple, powered)23100%
Oscill-SawInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment18600%
8 Cm Short Qd Angle AttachmentMotor, drill, electric17310%
Kincise Pinnacle Shell/Liner ImpactorMotor, surgical instrument, ac-powered171110%
11 0 Cm Long AttachmentMotor, drill, electric13000%
Power Module For Trauma Recon SystemBattery, replacement, rechargeable125510%
Battery OscillatorMotor, surgical instrument, ac-powered12200%
Quick Coupling For K-WiresInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment102280%
Sagittal Saw Attachment Long For TrsInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment99900%
8 0 Cm Medium AttachmentMotor, drill, electric9700%
Recon Sagittal Saw With Key For TrsMotor, surgical instrument, ac-powered88210%
Minimal Access AttachmentDrills, burrs, trephines & accessories (simple, powered)8410%
5 Cm Short AttachmentMotor, drill, electric7650%

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
HBCMotor, drill, electric7,37429.7%
HWEInstrument, surgical, orthopedic, ac-powered motor and accessory/attachment7,34629.6%
GEYMotor, surgical instrument, ac-powered5,24521.2%
ERLDrill, surgical, ent (electric or pneumatic) including handpiece2,96712%
HBEDrills, burrs, trephines & accessories (simple, powered)9593.9%
HBBMotor, drill, pneumatic5502.2%
MOQBattery, replacement, rechargeable2260.9%
GFABlade, saw, general & plastic surgery, surgical630.3%
GFFBur, surgical, general & plastic surgery260.1%
HSZInstrument, surgical, orthopedic, pneumatic powered & accessory/attachment180.1%

Reports by month, five years

089177Sep 2021: 145Oct 2021: 79Nov 2021: 115Dec 2021: 972022Jan 2022: 111Feb 2022: 125Mar 2022: 138Apr 2022: 126May 2022: 93Jun 2022: 163Jul 2022: 153Aug 2022: 177Sep 2022: 129Oct 2022: 117Nov 2022: 168Dec 2022: 1432023Jan 2023: 136Feb 2023: 142Mar 2023: 157Apr 2023: 172May 2023: 168Jun 2023: 149Jul 2023: 143Aug 2023: 130Sep 2023: 121Oct 2023: 103Nov 2023: 143Dec 2023: 952024Jan 2024: 115Feb 2024: 105Mar 2024: 106Apr 2024: 96May 2024: 72Jun 2024: 100Jul 2024: 144Aug 2024: 82Sep 2024: 89Oct 2024: 105Nov 2024: 68Dec 2024: 832025Jan 2025: 68Feb 2025: 75Mar 2025: 62Apr 2025: 66May 2025: 64Jun 2025: 53Jul 2025: 61Aug 2025: 45Sep 2025: 33Oct 2025: 41Nov 2025: 29Dec 2025: 192026Jan 2026: 23Feb 2026: 26Mar 2026: 10Apr 2026: 26May 2026: 14Jun 2026: 25Jul 2026: 12Aug 2026: 6

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

Event type

Death0%5
Injury0.6%147
Malfunction99.4%24,641
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 Depuy Synthes Products reports

How many FDA device reports name Depuy Synthes Products as manufacturer?

24,793 reports through August 2026, 264 of them in the latest 12 months.

Which of its brands appear most often?

Emax 2 Plus Motor (3,405), High Speed Elec G1 Handpiece Air Cooled (1,073), 6 5cm Adult Crani Attachmt (1,039), Battery Handpiece/Modular For Trs (965) and Motor Assembly Xmax (883).

Which device types does it report on?

motor, drill, electric (29.7%), instrument, surgical, orthopedic, ac-powered motor and accessory/attachment (29.6%), motor, surgical instrument, ac-powered (21.2%) and drill, surgical, ent (electric or pneumatic) including handpiece (12%).

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.