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FDA product code HWR · class 1 · Orthopedic
Driver, prosthesis: medical device reports filed with FDA
9,800 reports carry this product code, 1996–2026; 30 brands with a page.
- 9,800
- reports with this product code
- 0% of all MAUDE reports
- 1,283
- reports, 12 months to August 2026
- 1,181 in the 12 months before
- 97.5%
- classified as malfunction
- 62.3% across all reports
- 0%
- classified as death, as reported
- 0.9% across all reports
Product code HWR is FDA's classification for "Driver, prosthesis" (orthopedic panel), a class 1 device. 9,800 medical device reports carry this product code, 0% of the MAUDE database, from September 1996 to August 2026.
1,283 reports arrived in the 12 months to August 2026, close to the 1,181 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 malfunction (97.5%) and injury (2.4%). 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 Spine | 2,810 | 28.7% |
| Depuy Ireland - 9616671 | 1,405 | 14.3% |
| Depuy Ireland - 3015516266 | 641 | 6.5% |
| Depuy International - 8010379 | 594 | 6.1% |
| Depuy Synthes Spine | 552 | 5.6% |
| Medos International S Rl Ch | 367 | 3.7% |
| Depuy Orthopaedics | 164 | 1.7% |
| Acumed | 128 | 1.3% |
| Depuy Ireland 9616671 | 109 | 1.1% |
| Depuy International 8010379 | 95 | 1% |
| Depuy Orthopaedics 1818910 | 69 | 0.7% |
| Depuy Ireland | 36 | 0.4% |
| Wright Medical Technology | 18 | 0.2% |
| Biomet UK | 15 | 0.2% |
| Biomet 3i | 7 | 0.1% |
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 | 5,009 | 51.1% |
| Material twisted/bent | 2,162 | 22.1% |
| Device-device incompatibility | 997 | 10.2% |
| Material deformation | 853 | 8.7% |
| Naturally worn | 424 | 4.3% |
| Crackthe device cracked | 320 | 3.3% |
| Fracturea broken bone | 235 | 2.4% |
| Entrapment of device | 142 | 1.4% |
| Mechanical jam | 108 | 1.1% |
| Mechanical problema mechanical problem | 108 | 1.1% |
| Material integrity problema problem with the device material | 90 | 0.9% |
| Device slipped | 85 | 0.9% |
| Component missing | 49 | 0.5% |
| Material fragmentation | 47 | 0.5% |
| Contamination /decontamination problem | 44 | 0.4% |
| Unintended movement | 40 | 0.4% |
| Scratched material | 36 | 0.4% |
| Detachment of device or device componentpart of the device came off | 29 | 0.3% |
| Physical resistance/sticking | 27 | 0.3% |
| Failure to cut | 25 | 0.3% |
Questions about driver, prosthesis reports
What is product code HWR?
FDA's classification code for "Driver, prosthesis", class 1, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
9,800 reports through August 2026, 1,283 of them in the latest 12 months.
Which brands appear most often?
Attune Femoral Introducer (1,425), Angled Acet Insertr (855), Cor/Tri Ant Stem Insert Shaft (840), Verse X25 Inserter/Tightener (683) and Retaining Stem Inserter (557). 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.