Nail, fixation, bone: medical device reports filed with FDA

7,240 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.

7,240
reports with this product code: 0% of all MAUDE reports; 354
reports, 12 months to August 2026: 551 in the 12 months before; 32%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code JDS is FDA's classification for "Nail, fixation, bone" (orthopedic panel), a class 2 device. 7,240 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to August 2026.

354 reports arrived in the 12 months to August 2026, down 36% from 551 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 (67.4%), malfunction (32%) and death (0.2%). 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
Aiming Arm/ Radiolucent	370	82	0%	100%
Insertion Handle/ Radiolucent Long	234	79	0%	100%
Trauma Implant	185	0	0.4%	1.1%
Unkn TRIGEN INTERTAN Intertroch Antegr Nail	136	3	0%	1.2%
Trigen	124	0	0%	5.3%
UNK - Guide/Compression/K-Wires	55	14	0%	70%
Unk - Nails	42	12	0%	57.8%
Unk - Nail Head Elements Fns Antirotation	26	6	0%	7.7%
UNK - Nails: TFNA	12	24	0%	20.6%
UNK - Nail Head Elements: TFNA Helical Blade	9	13	0%	23.3%
Unkn Taylor Spatial Frame Exfix Dev	9	0	0%	0%
Unk - Nail Head Elements Fns Bolt	8	12	0%	8.1%
Unknown T2 Tibia Nail	8	0	0%	0%
Unknown T2 Alpha Tibia Nail	5	175	0%	0%
130 Deg Aiming Arm F/Trochanteric Fixation Nails	4	0	0%	85.1%
UNK - Screws: Nail Distal Locking	3	12	0.2%	13.3%
Flexible Shaft W/Cir Connector	2	12	0%	87.5%
Unk - Nail Head Elements Pfna Blade	2	1	0%	6.5%
Disp Firstpass Str Passr Self	1	29	0%	73.5%
Inserter For Ti Elastic Nails	1	1	0%	97.4%
T-Handle	1	17	0%	90.2%
UNK - Screws: Locking	1	98	0%	14.3%

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 USA	961	13.3%
Smith & Nephew	707	9.8%
Wrights Lane Synthes USA Products	503	6.9%
Synthes	270	3.7%
Synthes Monument	242	3.3%
Stryker Osteosynthesis Kiel	207	2.9%
Oberdorf Synthes Produktions	193	2.7%
Stryker Trauma Kiel	160	2.2%
Smith & Nephew Orthopaedic Div	106	1.5%
Synthes Selzach	50	0.7%
Paragon 28	27	0.4%
Smith & Nephew Orthopaedics	23	0.3%
Zimmer Manufacturing	23	0.3%
Synthes Bettlach	22	0.3%
Howmedica	19	0.3%

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

Death0.2%11

Injury67.4%4,882

Malfunction32%2,318

Other0.2%11

Not given0.2%18

Who filed

Manufacturer report98.3%7,116

Voluntary report0.5%35

User facility report0%0

Distributor report0.4%29

Not given0.8%60

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,511	20.9%
Device-device incompatibility	984	13.6%
Fracturea broken bone	458	6.3%
Explanted	437	6%
Insufficient device problem information	414	5.7%
Replace	200	2.8%
Migration or expulsion of device	163	2.3%
Migrationthe device moved from where it was placed	145	2%
Device operates differently than expectedthe device behaved unexpectedly	134	1.9%
Material deformation	110	1.5%
Failure to align	81	1.1%
Detachment of device or device componentpart of the device came off	72	1%
Manufacturing, packaging or shipping problem	66	0.9%
Difficult to removethe device was hard to remove	64	0.9%
Material twisted/bent	63	0.9%
Fitting problem	56	0.8%
Device dislodged or dislocated	53	0.7%
Device slipped	53	0.7%
Bent	49	0.7%
Device remains implanted	49	0.7%

Questions about nail, fixation, bone reports

What is product code JDS?

FDA's classification code for "Nail, fixation, bone", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

7,240 reports through August 2026, 354 of them in the latest 12 months.

Which brands appear most often?

Aiming Arm/ Radiolucent (370), Insertion Handle/ Radiolucent Long (234), Trauma Implant (185), Unkn TRIGEN INTERTAN Intertroch Antegr Nail (136) and Trigen (124). 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.