Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment: medical device reports filed with FDA

2,860 reports carry this product code, 1997–2026; 17 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.

2,860
reports with this product code: 0% of all MAUDE reports; 8
reports, 12 months to August 2026: 6 in the 12 months before; 97.2%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KIJ is FDA's classification for "Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment" (general, Plastic Surgery panel), a class 1 device. 2,860 medical device reports carry this product code, 0% of the MAUDE database, from March 1997 to August 2026.

8 reports arrived in the 12 months to August 2026, up 33% from 6 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%), injury (2.7%) and death (0.1%). 17 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
System 6 Sagittal Saw	271	0	0%	99.1%
Dual Trigger Rotary	237	0	0%	99.7%
System 6 Aseptic Housing Assy	222	0	0%	99.6%
System 5 Sagittal Saw	207	0	0%	97.6%
Adj Pin Collet 2 0-3 2mm	183	0	0%	99.5%
System 5 Dual Trigger Rotary Handpiece	150	0	0%	98.7%
Single Trigger Rotary	124	0	0%	98.8%
Pin Collet	109	0	0%	99.5%
Sys 6 Recip	98	0	0%	100%
Cordless Driver 3	24	0	0%	99.8%
Wire Collet	24	3	0%	98.2%
Sagittal Saw Attachment	3	64	0%	99.3%
System 7 Sag Saw	3	0	0%	98.8%
Driver	1	27	0%	98.6%
Neptune Rover With Smoke Evac And Power Pole	1	0	0.4%	98.1%
System 7 Dual Trigger Rotary	1	0	0%	99.1%
Unknown Shoulder Metaglene	1	16	0.3%	8.5%

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	2,333	81.6%
Stryker Instruments-Kalamazoo	274	9.6%
Stryker Instruments	39	1.4%
Stryker Osteosynthesis Freiburg	7	0.2%
Stryker	4	0.1%
Stryker Endoscopy San Jose	2	0.1%
Stryker Ireland	2	0.1%
Stryker Leibinger Freiburg	2	0.1%
Acumed	1	0%
Advanced Bionics	1	0%
Depuy Ireland	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%2

Injury2.7%76

Malfunction97.2%2,780

Other0%1

Not given0%1

Who filed

Manufacturer report99.2%2,837

Voluntary report0.3%10

User facility report0%0

Distributor report0%0

Not given0.5%13

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	360	12.6%
Self-activation or keying	222	7.8%
Sticking	210	7.3%
Device slipped	202	7.1%
Breakthe device broke	201	7%
Overheating of device	163	5.7%
Device operates differently than expectedthe device behaved unexpectedly	138	4.8%
Leak/splashthe device leaked	124	4.3%
Component missing	117	4.1%
Detachment of device component	91	3.2%
Mechanical jam	90	3.1%
Metal shedding debris	86	3%
Device remains activated	78	2.7%
Component falling	77	2.7%
Nonstandard device	75	2.6%
Smoking	67	2.3%
Unintended power up	66	2.3%
Device contamination with chemical or other material	61	2.1%
Temperature problem	57	2%
Battery problema problem with the battery	46	1.6%

Questions about instrument, surgical, orthopedic, dc-powered motor and accessory/attachment reports

What is product code KIJ?

FDA's classification code for "Instrument, surgical, orthopedic, dc-powered motor and accessory/attachment", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,860 reports through August 2026, 8 of them in the latest 12 months.

Which brands appear most often?

System 6 Sagittal Saw (271), Dual Trigger Rotary (237), System 6 Aseptic Housing Assy (222), System 5 Sagittal Saw (207) and Adj Pin Collet 2 0-3 2mm (183). 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.