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FDA product code HTO · class 1 · Orthopedic
Reamer: medical device reports filed with FDA
29,443 reports carry this product code, 1992–2026; 30 brands with a page.
- 29,443
- reports with this product code
- 0.1% of all MAUDE reports
- 777
- reports, 12 months to August 2026
- 1,712 in the 12 months before
- 95.7%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code HTO is FDA's classification for "Reamer" (orthopedic panel), a class 1 device. 29,443 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.
777 reports arrived in the 12 months to August 2026, down 55% from 1,712 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 (95.7%), injury (4.1%) and other (0.1%). 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 |
|---|---|---|
| Depuy Orthopaedics US | 19,485 | 66.2% |
| Depuy Orthopaedics 1818910 | 1,364 | 4.6% |
| Wrights Lane Synthes USA Products | 831 | 2.8% |
| Depuy Orthopaedics | 761 | 2.6% |
| Depuy Ireland - 9616671 | 737 | 2.5% |
| Greatbatch Medical | 528 | 1.8% |
| Synthes Monument | 520 | 1.8% |
| Synthes | 378 | 1.3% |
| Depuy International - 8010379 | 262 | 0.9% |
| Depuy Orthopaedics US 1818910 | 179 | 0.6% |
| Synthes Bettlach | 164 | 0.6% |
| Depuy Orthopaedic 1818910 | 136 | 0.5% |
| Oberdorf Synthes Produktions | 98 | 0.3% |
| Synthes Selzach | 98 | 0.3% |
| Stryker Osteosynthesis Kiel | 58 | 0.2% |
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 |
|---|---|---|
| Failure to cut | 15,100 | 51.3% |
| Breakthe device broke | 4,014 | 13.6% |
| Dull, blunt | 3,751 | 12.7% |
| Naturally worn | 2,291 | 7.8% |
| Corrodedthe device corroded | 2,049 | 7% |
| Device-device incompatibility | 931 | 3.2% |
| Material twisted/bent | 720 | 2.4% |
| Material deformation | 588 | 2% |
| Entrapment of device | 451 | 1.5% |
| Illegible information | 309 | 1% |
| Fracturea broken bone | 302 | 1% |
| Crackthe device cracked | 231 | 0.8% |
| Detachment of device component | 195 | 0.7% |
| Contamination /decontamination problem | 189 | 0.6% |
| Material fragmentation | 162 | 0.6% |
| Material discolored | 150 | 0.5% |
| Detachment of device or device componentpart of the device came off | 134 | 0.5% |
| Mechanical jam | 116 | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 103 | 0.3% |
| Scratched material | 98 | 0.3% |
Questions about reamer reports
What is product code HTO?
FDA's classification code for "Reamer", class 1, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
29,443 reports through August 2026, 777 of them in the latest 12 months.
Which brands appear most often?
Quickset Ace Grater Head 51mm (1,200), Quickset Ace Grater Head 49mm (1,169), Quickset Ace Grater Head 53mm (1,153), Quickset Ace Grater Head 47mm (1,124) and Quickset Ace Grater Head 55mm (1,112). 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.