Reported Reactions

Devices › Nail, fixation, bone

Device brand name · Nail fixation bone

Unkn TRIGEN INTERTAN Intertroch Antegr Nail: medical device reports filed with FDA

169 reports name it, 2022–2026. Manufacturer given most often on reports: Smith & Nephew. Product code JDS.

169
device reports naming the brand
0% of all MAUDE reports · about 40 a year
3
reports, 12 months to August 2026
0 in the 12 months before
1.2%
classified as malfunction
32% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 169 reports that name the brand "Unkn TRIGEN INTERTAN Intertroch Antegr Nail" (nail fixation bone), received between April 2022 and August 2026; the manufacturer given most often on reports is Smith & Nephew. Spellings of one product vary from report to report.

3 reports arrived in the 12 months to August 2026, with 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 injury (98.8%) and malfunction (1.2%); across all nail, fixation, bone reports (product code JDS) death is recorded in 0.2% and malfunction in 32%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are fracture (3%), malposition of device (2.4%) and loosening of implant not related to bone-ingrowth (1.8%). The patient problems coded most often are deformity/ disfigurement, thrombosis/thrombus and bone fracture(s). 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

057114Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 114May 2022: 33Jun 2022: 10Jul 2022: 0Aug 2022: 6Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 1Mar 2024: 2Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 1May 2026: 0Jun 2026: 0Jul 2026: 1Aug 2026: 1

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

0821632022: 16320222024: 320242026: 32026

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.8%167
Malfunction1.2%2
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%169
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 7,240 reports carrying product code JDS. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Fracturea broken bone53%6.3%
Malposition of device42.4%0.3%
Loosening of implant not related to bone-ingrowth31.8%0.3%
Migration or expulsion of device31.8%2.3%
Loss of osseointegration21.2%0%
Migrationthe device moved from where it was placed21.2%2%
Breakthe device broke10.6%20.9%
Component missing10.6%0.1%
Material deformation10.6%1.5%

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)ReportsShare
Deformity/ disfigurement3017.8%
Thrombosis/thrombus2313.6%
Bone fracture(s)1810.7%
Malunion of bone148.3%
Failure of implant137.7%
Nonunion/delayed-union bone fracture105.9%
Post operative wound infection105.9%
Hip fracturea broken hip42.4%
Impaired healingslow healing42.4%
Inadequate osseointegration42.4%
Limb fracture42.4%
Loss of range of motion42.4%
Appropriate clinical signs, symptoms and conditions term/code not available31.8%
Necrosisdeath of tissue31.8%
Perforation31.8%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureUnkn TRIGEN INTERTAN Intertroch Antegr NailProduct code JDSAll MAUDE reports
Reports1697,24026,136,888
Share of that pool—2.3%0%
Classified as death, per 1,000 reports029
Classified as injury98.8%67.4%36.2%
Classified as malfunction1.2%32%62.3%
Filed by the manufacturer100%98.3%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 JDS

BrandReportsLatest 12 monthsClassified as death
Aiming Arm/ Radiolucent465820%
Insertion Handle/ Radiolucent Long240790%
Trauma Implant26400.4%
Trigen22800%
UNK - Guide/Compression/K-Wires213140%
Unk - Nails180120%
Unk - Nail Head Elements Fns Antirotation18260%
UNK - Nails: TFNA412240%
UNK - Nail Head Elements: TFNA Helical Blade270130%
Unkn Taylor Spatial Frame Exfix Dev17500%
Unk - Nail Head Elements Fns Bolt185120%
Unknown T2 Tibia Nail22300%
Unknown T2 Alpha Tibia Nail1991750%
130 Deg Aiming Arm F/Trochanteric Fixation Nails21500%
UNK - Screws: Nail Distal Locking444120.2%

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 Unkn TRIGEN INTERTAN Intertroch Antegr Nail reports

How many FDA reports name Unkn TRIGEN INTERTAN Intertroch Antegr Nail?

169 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.

What kinds of events are reported?

injury (98.8%) and malfunction (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (3%), malposition of device (2.4%), loosening of implant not related to bone-ingrowth (1.8%), migration or expulsion of device (1.8%) and loss of osseointegration (1.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Unkn TRIGEN INTERTAN Intertroch Antegr Nail 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.