Devices › Rod, fixation, intramedullary and accessories
Device brand name · Intramedullary fixation rod
Sign Im Nail: medical device reports filed with FDA
2,301 reports name it, 2013–2026. Manufacturer given most often on reports: Sign Fracture Care International. Product code HSB.
- 2,301
- device reports naming the brand
- 0% of all MAUDE reports · about 174 a year
- 226
- reports, 12 months to August 2026
- 226 in the 12 months before
- 9%
- classified as malfunction
- 33% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
2,301 medical device reports received by FDA name the brand "Sign Im Nail" (intramedullary fixation rod); the manufacturer given most often on reports is Sign Fracture Care International; received from April 2013 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
226 reports arrived in the 12 months to August 2026, close to the 226 of 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 (91%) and malfunction (9%); across all rod, fixation, intramedullary and accessories reports (product code HSB) death is recorded in 0.3% and malfunction in 33%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (27.8%), device handling problem (2.3%) and insufficient device problem information (0.9%). The patient problems coded most often are limb fracture, bone fracture(s) and post operative wound infection. 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 37,835 reports carrying product code HSB. 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 |
|---|---|---|---|
| Breakthe device broke | 640 | 27.8% | 21.8% |
| Device handling problem | 54 | 2.3% | 0.2% |
| Insufficient device problem information | 20 | 0.9% | 2.7% |
| Migrationthe device moved from where it was placed | 19 | 0.8% | 6.1% |
| Failure to adhere or bond | 16 | 0.7% | 0.4% |
| Fracturea broken bone | 14 | 0.6% | 8.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 0.3% | 2.7% |
| Loose or intermittent connection | 6 | 0.3% | 0.3% |
| Improper or incorrect procedure or method | 4 | 0.2% | 0.6% |
| Migration or expulsion of device | 4 | 0.2% | 3% |
| Activation, positioning or separation problem | 3 | 0.1% | 0.1% |
| Bent | 3 | 0.1% | 0.4% |
| Difficult to insertthe device was hard to insert | 3 | 0.1% | 1% |
| Failure to osseointegrate | 3 | 0.1% | 0.1% |
| Inadequacy of device shape and/or size | 3 | 0.1% | 0.3% |
| Positioning problem | 3 | 0.1% | 0.5% |
| Unstable | 3 | 0.1% | 0.1% |
| Device dislodged or dislocated | 2 | 0.1% | 1% |
| Human-device interface problem | 2 | 0.1% | 0.1% |
| Malposition of device | 2 | 0.1% | 0.9% |
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) | Reports | Share |
|---|---|---|
| Limb fracture | 1,112 | 48.3% |
| Bone fracture(s) | 1,014 | 44.1% |
| Post operative wound infection | 148 | 6.4% |
| Nonunion/delayed-union bone fracture | 72 | 3.1% |
| Device embedded in tissue or plaque | 10 | 0.4% |
| Medical device site infectioninfection at the device site | 10 | 0.4% |
| Impaired healingslow healing | 5 | 0.2% |
| Falla fall | 4 | 0.2% |
| Inadequate osseointegration | 3 | 0.1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.1% |
| Test result | 2 | 0.1% |
| Failure of implant | 1 | 0% |
| Purulent discharge | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sign Im Nail | Product code HSB | All MAUDE reports |
|---|---|---|---|
| Reports | 2,301 | 37,835 | 26,136,888 |
| Share of that pool | — | 6.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 91% | 66.3% | 36.2% |
| Classified as malfunction | 9% | 33% | 62.3% |
| Filed by the manufacturer | 100% | 98.9% | 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 HSB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| UNK - Nails: TFNA | 412 | 24 | 0% |
| Trochanteric Nail Kit Ti Gamma3 11x180mm X 125 | 366 | 0 | 0.3% |
| Unknown T2 Scn | 355 | 0 | 0% |
| SIGN Fin NAIL | 335 | 50 | 0% |
| UNK - Nail Head Elements: TFNA Helical Blade | 270 | 13 | 0% |
| Unk - Nail Head Elements Pfna Blade | 260 | 1 | 0% |
| Radiolucent Insertion Handle Frn | 256 | 14 | 0% |
| Helical Blade/Screw Coupling Screw | 226 | 41 | 0% |
| Precice Stryde System | 226 | 0 | 0% |
| Lag Screw Driver | 223 | 14 | 0% |
| Unknown T2 Tibia Nail | 223 | 0 | 0% |
| Cannulated Connecting Screw | 206 | 27 | 0% |
| Target Device Gamma3 300x160mm | 239 | 1 | 0% |
| Unknown T2 Alpha Tibia Nail | 199 | 175 | 0% |
| Unknown Kie Product | 219 | 21 | 0.5% |
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." 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 Sign Im Nail reports
How many FDA reports name Sign Im Nail?
2,301 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 226 in the latest 12 months.
What kinds of events are reported?
injury (91%) and malfunction (9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (27.8%), device handling problem (2.3%), insufficient device problem information (0.9%), migration (0.8%) and failure to adhere or bond (0.7%). 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 Sign Im 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.