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FDA product code HSB · class 2 · Orthopedic
Rod, fixation, intramedullary and accessories: medical device reports filed with FDA
37,835 reports carry this product code, 1992–2026; 30 brands with a page.
- 37,835
- reports with this product code
- 0.1% of all MAUDE reports
- 2,813
- reports, 12 months to August 2026
- 2,532 in the 12 months before
- 33%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code HSB is FDA's classification for "Rod, fixation, intramedullary and accessories" (orthopedic panel), a class 2 device. 37,835 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1992 to August 2026.
2,813 reports arrived in the 12 months to August 2026, up 11% from 2,532 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 (66.3%), malfunction (33%) and death (0.3%). 30 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
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 | 6,415 | 17% |
| Stryker Trauma Kiel | 5,145 | 13.6% |
| Sign Fracture Care International | 2,763 | 7.3% |
| Stryker | 2,733 | 7.2% |
| Wrights Lane Synthes USA Products | 2,689 | 7.1% |
| Smith & Nephew | 2,204 | 5.8% |
| Oberdorf Synthes Produktions | 1,990 | 5.3% |
| Synthes USA | 1,909 | 5% |
| Synthes Monument | 953 | 2.5% |
| Zimmer | 897 | 2.4% |
| Stryker Osteosynthesis Kiel | 865 | 2.3% |
| Zimmer Biomet | 756 | 2% |
| Nuvasive Specialized Orthopedics | 645 | 1.7% |
| Zimmer Switzerland Manufacturing | 629 | 1.7% |
| Synthes Elmira | 526 | 1.4% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Breakthe device broke | 8,252 | 21.8% |
| Fracturea broken bone | 3,052 | 8.1% |
| Device-device incompatibility | 2,967 | 7.8% |
| Migrationthe device moved from where it was placed | 2,309 | 6.1% |
| Migration or expulsion of device | 1,135 | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 1,036 | 2.7% |
| Insufficient device problem information | 1,020 | 2.7% |
| Failure to align | 737 | 1.9% |
| Explanted | 513 | 1.4% |
| Material twisted/bent | 495 | 1.3% |
| Material deformation | 424 | 1.1% |
| Mechanical jam | 421 | 1.1% |
| Difficult to insertthe device was hard to insert | 369 | 1% |
| Device dislodged or dislocated | 362 | 1% |
| Malposition of device | 352 | 0.9% |
| Mechanical problema mechanical problem | 332 | 0.9% |
| Difficult to removethe device was hard to remove | 314 | 0.8% |
| Fitting problem | 286 | 0.8% |
| Packaging problem | 286 | 0.8% |
| Device slipped | 279 | 0.7% |
Questions about rod, fixation, intramedullary and accessories reports
What is product code HSB?
FDA's classification code for "Rod, fixation, intramedullary and accessories", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
37,835 reports through August 2026, 2,813 of them in the latest 12 months.
Which brands appear most often?
Sign Im Nail (2,301), UNK - Nails: TFNA (398), Trochanteric Nail Kit Ti Gamma3 11x180mm X 125 (365), Unknown T2 Scn (355) and SIGN Fin NAIL (335). 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.