Devices › Nail, fixation, bone
Device brand name · Nail fixation bone
Insertion Handle/ Radiolucent Long: medical device reports filed with FDA
240 reports name it, 2022–2026. Manufacturer given most often on reports: Synthes. Product code JDS.
- 240
- device reports naming the brand
- 0% of all MAUDE reports · about 55 a year
- 79
- reports, 12 months to August 2026
- 104 in the 12 months before
- 100%
- 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 240 reports that name the brand "Insertion Handle/ Radiolucent Long" (nail fixation bone), received between March 2022 and August 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.
79 reports arrived in the 12 months to August 2026, down 24% from 104 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 (100%); 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 device-device incompatibility (89.6%), break (7.5%) and material deformation (4.2%). 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
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
Event type and report source
Event type, as classified on the report
Who filed the report
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) | Reports | Share | Share across product code |
|---|---|---|---|
| Device-device incompatibility | 215 | 89.6% | 13.6% |
| Breakthe device broke | 18 | 7.5% | 20.9% |
| Material deformation | 10 | 4.2% | 1.5% |
| Material twisted/bent | 8 | 3.3% | 0.9% |
| Crackthe device cracked | 3 | 1.3% | 0.4% |
| Illegible information | 3 | 1.3% | 0.1% |
| Material integrity problema problem with the device material | 2 | 0.8% | 0.3% |
| Defective devicethe device was defective | 1 | 0.4% | 0.1% |
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.
In context
| Measure | Insertion Handle/ Radiolucent Long | Product code JDS | All MAUDE reports |
|---|---|---|---|
| Reports | 240 | 7,240 | 26,136,888 |
| Share of that pool | — | 3.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 0% | 67.4% | 36.2% |
| Classified as malfunction | 100% | 32% | 62.3% |
| Filed by the manufacturer | 100% | 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
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Aiming Arm/ Radiolucent | 465 | 82 | 0% |
| Trauma Implant | 264 | 0 | 0.4% |
| Unkn TRIGEN INTERTAN Intertroch Antegr Nail | 169 | 3 | 0% |
| Trigen | 228 | 0 | 0% |
| UNK - Guide/Compression/K-Wires | 213 | 14 | 0% |
| Unk - Nails | 180 | 12 | 0% |
| Unk - Nail Head Elements Fns Antirotation | 182 | 6 | 0% |
| UNK - Nails: TFNA | 412 | 24 | 0% |
| UNK - Nail Head Elements: TFNA Helical Blade | 270 | 13 | 0% |
| Unkn Taylor Spatial Frame Exfix Dev | 175 | 0 | 0% |
| Unk - Nail Head Elements Fns Bolt | 185 | 12 | 0% |
| Unknown T2 Tibia Nail | 223 | 0 | 0% |
| Unknown T2 Alpha Tibia Nail | 199 | 175 | 0% |
| 130 Deg Aiming Arm F/Trochanteric Fixation Nails | 215 | 0 | 0% |
| UNK - Screws: Nail Distal Locking | 444 | 12 | 0.2% |
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 Insertion Handle/ Radiolucent Long reports
How many FDA reports name Insertion Handle/ Radiolucent Long?
240 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 79 in the latest 12 months.
What kinds of events are reported?
malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device-device incompatibility (89.6%), break (7.5%), material deformation (4.2%), material twisted/bent (3.3%) and crack (1.3%). 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 Insertion Handle/ Radiolucent Long 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.