Devices › Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Device brand name · Instrument surgical orthopedic ac-powered motor and accessory/attachment
Unknown Instruments Product: medical device reports filed with FDA
400 reports name it, 2013–2026. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code HWE.
- 400
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 23
- reports, 12 months to August 2026
- 27 in the 12 months before
- 80.5%
- classified as malfunction
- 97.5% across the product code
- 0.8%
- classified as death, as reported
- 3 reports · not verified by FDA
400 medical device reports received by FDA name the brand "Unknown Instruments Product" (instrument surgical orthopedic ac-powered motor and accessory/attachment); the manufacturer given most often on reports is Stryker Instruments-Kalamazoo; received from February 2013 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
23 reports arrived in the 12 months to August 2026, down 15% from 27 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 (80.5%), injury (18.8%) and death (0.8%); across all instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports (product code HWE) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (15.3%), overheating of device (14.2%) and fracture (12.5%). The patient problems coded most often are no patient involvement, burn(s) and erosion. 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 50,440 reports carrying product code HWE. 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 | 61 | 15.3% | 8.2% |
| Overheating of device | 57 | 14.2% | 4.2% |
| Fracturea broken bone | 50 | 12.5% | 4.4% |
| Detachment of device or device componentpart of the device came off | 31 | 7.8% | 2.9% |
| Disassembly | 16 | 4% | 1.7% |
| Device remains activated | 12 | 3% | 1.2% |
| Insufficient device problem information | 10 | 2.5% | 0.1% |
| Fluid/blood leak | 9 | 2.3% | 1.4% |
| Unintended power up | 9 | 2.3% | 0.9% |
| Biocompatibility | 8 | 2% | 0.1% |
| Material frayed | 7 | 1.8% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 1.5% | 5.9% |
| Material split, cut or torn | 6 | 1.5% | 0.1% |
| Leak/splashthe device leaked | 5 | 1.3% | 1.2% |
| Material deformation | 5 | 1.3% | 0.6% |
| Material fragmentation | 5 | 1.3% | 0.9% |
| Incorrect measurementthe device measured wrongly | 4 | 1% | 0% |
| Unintended movement | 4 | 1% | 0.3% |
| Flaked | 3 | 0.8% | 0.3% |
| Material disintegration | 3 | 0.8% | 0.5% |
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 |
|---|---|---|
| No patient involvement | 64 | 16% |
| Burn(s)a burn | 13 | 3.3% |
| Erosion | 13 | 3.3% |
| Painpain, site not specified | 7 | 1.8% |
| Wound dehiscencea wound reopened | 6 | 1.5% |
| Necrosisdeath of tissue | 5 | 1.3% |
| Tissue breakdown | 5 | 1.3% |
| Abrasion | 4 | 1% |
| Blistera blister | 3 | 0.8% |
| Hemorrhage/blood loss/bleeding | 3 | 0.8% |
| Hypersensitivity/allergic reaction | 3 | 0.8% |
| Injurya physical injury | 3 | 0.8% |
| Partial thickness (second degree) burn | 3 | 0.8% |
| Tissue damage | 3 | 0.8% |
| Blood loss | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Instruments Product | Product code HWE | All MAUDE reports |
|---|---|---|---|
| Reports | 400 | 50,440 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 8 | 0 | 9 |
| Classified as injury | 18.8% | 2.3% | 36.2% |
| Classified as malfunction | 80.5% | 97.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 HWE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Small Battery Drive | 2,439 | 0 | 0% |
| Colibri | 1,472 | 0 | 0% |
| Electric Pen Drive 60 000 Rpm | 1,486 | 94 | 0% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Smartlife Large Aspetic Housing | 1,132 | 2 | 0% |
| Sagittal Saw Attachment Long For Trs | 1,039 | 90 | 0% |
| Quick Coupling For K-Wires | 744 | 28 | 0% |
| Epd 60000 Rpm | 737 | 0 | 0% |
| Air Oscillator | 657 | 0 | 0% |
| Chuck With Key/Drill Speed For Trs | 655 | 94 | 0% |
| Small Battery Drive Colibri | 633 | 0 | 0% |
| Modular Calcar Planer Sml | 515 | 30 | 0% |
| Sagittal Saw Attachment For Trs | 428 | 77 | 0% |
| System 6 Sagittal Saw | 698 | 0 | 0% |
| Unium Modular Handpiece | 403 | 137 | 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 Unknown Instruments Product reports
How many FDA reports name Unknown Instruments Product?
400 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 23 in the latest 12 months.
What kinds of events are reported?
malfunction (80.5%), injury (18.8%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (15.3%), overheating of device (14.2%), fracture (12.5%), detachment of device or device component (7.8%) and disassembly (4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Instruments Product 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.