Devices › Driver, wire, and bone drill, manual
Device brand name · Drill surgical ent electric or pneumatic including handpiece
Core Impaction Drill: medical device reports filed with FDA
3,913 reports name it, 2007–2018. Manufacturer given most often on reports: Stryker Instruments-Kalamazoo. Product code DZJ.
- 3,913
- device reports naming the brand
- 0% of all MAUDE reports · about 201 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.7%
- classified as malfunction
- 96.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 3,913 reports that name the brand "Core Impaction Drill" (drill surgical ent electric or pneumatic including handpiece), received between January 2007 and October 2018; the manufacturer given most often on reports is Stryker Instruments-Kalamazoo. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (98.7%) and injury (1.3%); across all driver, wire, and bone drill, manual reports (product code DZJ) death is recorded in 0% and malfunction in 96.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are overheating of device (90.2%), smoking (2.8%) and temperature problem (2.6%). The patient problems coded most often are no patient involvement, burn(s) and bacterial infection. 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
No report naming Core Impaction Drill was received in the five years to August 2026; the latest was received in October 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 3,406 reports carrying product code DZJ. 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 |
|---|---|---|---|
| Overheating of device | 3,528 | 90.2% | 71.7% |
| Smoking | 111 | 2.8% | 2.5% |
| Temperature problem | 103 | 2.6% | 4.9% |
| Fluid/blood leak | 36 | 0.9% | 2% |
| Leak/splashthe device leaked | 31 | 0.8% | 1% |
| Unintended movement | 22 | 0.6% | 0.4% |
| Device remains activated | 18 | 0.5% | 1.3% |
| Device displays incorrect message | 17 | 0.4% | 5% |
| Breakthe device broke | 15 | 0.4% | 2.1% |
| Melted | 12 | 0.3% | 0.5% |
| Detachment of device component | 11 | 0.3% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 0.3% | 0.7% |
| Self-activation or keying | 11 | 0.3% | 1.6% |
| Detachment of device or device componentpart of the device came off | 8 | 0.2% | 0.2% |
| Sparking | 7 | 0.2% | 0.2% |
| Unintended power up | 7 | 0.2% | 0.9% |
| Unstable | 7 | 0.2% | 0.1% |
| Bent | 5 | 0.1% | 0% |
| Unintended system motionthe device moved when it should not have | 5 | 0.1% | 1.3% |
| Device inoperablethe device could not be used | 4 | 0.1% | 0.1% |
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 | 1,014 | 25.9% |
| Burn(s)a burn | 17 | 0.4% |
| Bacterial infectiona bacterial infection | 15 | 0.4% |
| Burn, thermal | 15 | 0.4% |
| Superficial (first degree) burn | 10 | 0.3% |
| Partial thickness (second degree) burn | 9 | 0.2% |
| Fluid discharge | 7 | 0.2% |
| Painpain, site not specified | 6 | 0.2% |
| Swellingswelling | 6 | 0.2% |
| Laceration(s) | 5 | 0.1% |
| Injurya physical injury | 2 | 0.1% |
| Abrasion | 1 | 0% |
| Bone fracture(s) | 1 | 0% |
| Chemical exposure | 1 | 0% |
| Erythemaskin redness | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Core Impaction Drill | Product code DZJ | All MAUDE reports |
|---|---|---|---|
| Reports | 3,913 | 3,406 | 26,136,888 |
| Share of that pool | — | 114.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 1.3% | 3.3% | 36.2% |
| Classified as malfunction | 98.7% | 96.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.5% | 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 DZJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Repair Core Impaction Drill | 206 | 0 | 0% |
| Tps Handpiece Cord | 580 | 0 | 0% |
| Loaner Core Impaction Drill | 154 | 0 | 0% |
| Tps Micro Driver | 165 | 0 | 0% |
| Core Micro Drill | 670 | 0 | 0% |
| Micro Drill Medium Straight Attachment | 312 | 0 | 0% |
| Micro Sagittal Saw | 1,395 | 0 | 0% |
| Micro Reciprocating Saw | 376 | 0 | 0% |
| Core Sumex Drill | 522 | 0 | 0% |
| Micro Drill | 190 | 0 | 0% |
| Impaction Bur Guard | 164 | 0 | 0% |
| Remb Micro Drill | 231 | 0 | 0% |
| Core Universal Driver | 679 | 0 | 0% |
| Micro Oscillating Saw | 346 | 0 | 0% |
| Remb Sag Saw | 267 | 0 | 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 Core Impaction Drill reports
How many FDA reports name Core Impaction Drill?
3,913 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.7%) and injury (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
overheating of device (90.2%), smoking (2.8%), temperature problem (2.6%), fluid/blood leak (0.9%) and leak/splash (0.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Core Impaction Drill 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.