Appliance, fixation, nail/blade/plate combination, multiple component: medical device reports filed with FDA

10,126 reports carry this product code, 1995–2026; 27 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.

10,126
reports with this product code: 0% of all MAUDE reports; 579
reports, 12 months to August 2026: 697 in the 12 months before; 29.1%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code KTT is FDA's classification for "Appliance, fixation, nail/blade/plate combination, multiple component" (orthopedic panel), a class 2 device. 10,126 medical device reports carry this product code, 0% of the MAUDE database, from April 1995 to August 2026.

579 reports arrived in the 12 months to August 2026, down 17% from 697 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 injury (70.3%), malfunction (29.1%) and death (0.3%). 27 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
UNK - Constructs: DHS/DCS	242	17	1.9%	0.7%
Femoral Neck System Plate 1 Hole - Sterile	203	1	0%	9.9%
Unknown Hoffmann Lrf	181	0	0%	0%
R3 Depth Gauge	153	12	0%	84.4%
Unk - Nail Head Elements Fns Bolt	132	12	0%	8.1%
Unk - Nail Head Elements Fns Antirotation	114	6	0%	7.7%
UNK - Screws: FNS Locking	95	25	0%	23.3%
Trauma Implant	32	0	0.4%	1.1%
Unk - Constructs Pfna	20	0	1.2%	2.4%
UNK - Constructs: Plate/Screws	18	9	0%	0.2%
Helical Blade Coupling Screw	17	0	0%	90.5%
Unkn Taylor Spatial Frame Exfix Dev	17	0	0%	0%
T-Handle	13	17	0%	90.2%
Unknown Apex Pin	10	0	0.5%	0.3%
Ebi Xfix Dynafix	7	0	0%	73.8%
Unk Screw	3	63	0%	7.2%
Locking Screw	2	3	0%	17.8%
R3 Straight Shell Impactor	2	21	0%	91.2%
UNK - Screws: Locking	2	98	0%	14.3%
2 5mm Drill Bit/Qc/Gold/110mm	1	14	0%	74.1%
Cable Tensioner	1	0	0%	96.4%
Cannulated 4 0mm Hexagonal Screwdriver	1	9	0%	91.7%
Standard Insertion Handle	1	0	0%	81.3%
Ti Pangea Locking Cap	1	0	0%	8.6%
Unk - Plates	1	0	0%	5.5%
Unk - Plates Trauma	1	34	0%	29.1%
Unknown Kie Product	1	21	0.5%	7.3%

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
Synthes	1,951	19.3%
Oberdorf Synthes Produktions	1,281	12.7%
Stryker	1,055	10.4%
Synthes USA	945	9.3%
Wrights Lane Synthes USA Products	619	6.1%
Orthofix	264	2.6%
Synthes Bettlach	236	2.3%
Synthes Elmira	206	2%
Synthes Monument	100	1%
Howmedica	96	0.9%
Stryker Osteosynthesis Selzach	95	0.9%
Wright Medical Technology	46	0.5%
Stryker Trauma Kiel	44	0.4%
Nuvasive Specialized Orthopedics	26	0.3%
Stryker Leibinger Freiburg	20	0.2%

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

Death0.3%28

Injury70.3%7,118

Malfunction29.1%2,948

Other0.2%23

Not given0.1%9

Who filed

Manufacturer report99.1%10,032

Voluntary report0.2%22

User facility report0%0

Distributor report0%1

Not given0.7%71

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	2,245	22.2%
Device-device incompatibility	563	5.6%
Migrationthe device moved from where it was placed	549	5.4%
Fracturea broken bone	411	4.1%
Insufficient device problem information	322	3.2%
Crackthe device cracked	298	2.9%
Device operates differently than expectedthe device behaved unexpectedly	275	2.7%
Mechanical problema mechanical problem	257	2.5%
Explanted	246	2.4%
Device slipped	194	1.9%
Migration or expulsion of device	171	1.7%
Material twisted/bent	125	1.2%
Material deformation	115	1.1%
Difficult to removethe device was hard to remove	114	1.1%
Fitting problem	107	1.1%
Unintended movement	106	1%
Replace	103	1%
Detachment of device component	100	1%
Mechanical jam	98	1%
Device dislodged or dislocated	83	0.8%

Questions about appliance, fixation, nail/blade/plate combination, multiple component reports

What is product code KTT?

FDA's classification code for "Appliance, fixation, nail/blade/plate combination, multiple component", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

10,126 reports through August 2026, 579 of them in the latest 12 months.

Which brands appear most often?

UNK - Constructs: DHS/DCS (242), Femoral Neck System Plate 1 Hole - Sterile (203), Unknown Hoffmann Lrf (181), R3 Depth Gauge (153) and Unk - Nail Head Elements Fns Bolt (132). 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.