Driver, wire, and bone drill, manual: medical device reports filed with FDA

3,406 reports carry this product code, 1992–2026; 22 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,406
reports with this product code: 0% of all MAUDE reports; 25
reports, 12 months to August 2026: 10 in the 12 months before; 96.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code DZJ is FDA's classification for "Driver, wire, and bone drill, manual" (dental panel), a class 2 device. 3,406 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

25 reports arrived in the 12 months to August 2026, up 150% from 10 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 (96.5%), injury (3.3%) and other (0.1%). 22 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Core Impaction Drill	2,206	0	0%	98.7%
Repair Core Impaction Drill	196	0	0%	98.5%
Tps Handpiece Cord	188	0	0%	99.5%
Loaner Core Impaction Drill	91	0	0%	98.1%
Tps Micro Driver	59	0	0%	97.6%
Core Micro Drill	54	0	0%	98.4%
Micro Drill Medium Straight Attachment	47	0	0%	89.4%
Micro Sagittal Saw	39	0	0%	99.4%
Micro Reciprocating Saw	36	0	0%	98.7%
Core Sumex Drill	29	0	0%	98.9%
Micro Drill	18	0	0%	98.4%
Impaction Bur Guard	14	0	0%	91.5%
Remb Micro Drill	14	0	0%	98.3%
Core Universal Driver	12	0	0%	99.4%
Micro Oscillating Saw	7	0	0%	97.1%
Remb Sag Saw	5	0	0%	98.5%
Unknown Instruments Product	4	23	0.8%	80.5%
Tps Universal Driver	3	0	0%	99.3%
Angled Long Saber Attachment	1	0	0.5%	98%
Core Saber Drill	1	0	0%	98.8%
Shaft For 90 Screwdriver	1	7	0%	98.1%
Universal Drill	1	0	0%	100%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Stryker Instruments Kalamazoo	1,808	53.1%
Stryker Instruments-Kalamazoo	1,311	38.5%
Stryker Instruments	36	1.1%
Stryker Ireland	3	0.1%
Synthes USA	1	0%

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 and report source

Event type

Death0%1

Injury3.3%113

Malfunction96.5%3,287

Other0.1%2

Not given0.1%3

Who filed

Manufacturer report99.5%3,390

Voluntary report0.1%4

User facility report0%0

Distributor report0%0

Not given0.4%12

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Overheating of device	2,442	71.7%
Device displays incorrect message	171	5%
Temperature problem	168	4.9%
Smoking	85	2.5%
Breakthe device broke	72	2.1%
Fluid/blood leak	68	2%
Self-activation or keying	56	1.6%
Device remains activated	45	1.3%
Unintended system motionthe device moved when it should not have	45	1.3%
Leak/splashthe device leaked	33	1%
Unintended power up	31	0.9%
Insufficient device problem information	26	0.8%
Device operates differently than expectedthe device behaved unexpectedly	25	0.7%
Melted	18	0.5%
Unintended movement	15	0.4%
Detachment of device component	13	0.4%
Component falling	12	0.4%
Patient-device incompatibilitythe device did not suit the patient	9	0.3%
Detachment of device or device componentpart of the device came off	8	0.2%
Inadequacy of device shape and/or size	7	0.2%

Questions about driver, wire, and bone drill, manual reports

What is product code DZJ?

FDA's classification code for "Driver, wire, and bone drill, manual", class 2, reviewed by the dental panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,406 reports through August 2026, 25 of them in the latest 12 months.

Which brands appear most often?

Core Impaction Drill (2,206), Repair Core Impaction Drill (196), Tps Handpiece Cord (188), Loaner Core Impaction Drill (91) and Tps Micro Driver (59). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.