Devices › Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Device brand name · Instrument surgical orthopedic ac-powered motor/access and attachment
Radiolucent-Drive: medical device reports filed with FDA
308 reports name it, 2013–2025. Manufacturer given most often on reports: Synthes. Product code HWE.
- 308
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 7 in the 12 months before
- 97.1%
- classified as malfunction
- 97.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
308 medical device reports received by FDA name the brand "Radiolucent-Drive" (instrument surgical orthopedic ac-powered motor/access and attachment); the manufacturer given most often on reports is Synthes; received from June 2013 to March 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 7 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 (97.1%) and injury (2.9%); across all instrument, surgical, orthopedic, ac-powered motor and accessory/attachment reports (product code HWE) death is recorded in 0% and malfunction in 97.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device inoperable (21.4%), mechanical jam (16.6%) and noise, audible (15.3%). The patient problems coded most often are no patient involvement, not applicable and bone fracture(s). 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 50,440 reports carrying product code HWE. 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 inoperablethe device could not be used | 66 | 21.4% | 6.8% |
| Mechanical jam | 51 | 16.6% | 13.1% |
| Noise, audible | 47 | 15.3% | 6.1% |
| Device operates differently than expectedthe device behaved unexpectedly | 37 | 12% | 5.9% |
| Complete loss of power | 31 | 10.1% | 7.5% |
| Excessive heating | 29 | 9.4% | 3.5% |
| Overheating of device | 13 | 4.2% | 4.2% |
| Mechanical problema mechanical problem | 11 | 3.6% | 2.3% |
| Detachment of device or device componentpart of the device came off | 10 | 3.2% | 2.9% |
| Detachment of device component | 9 | 2.9% | 0.9% |
| Breakthe device broke | 7 | 2.3% | 8.2% |
| Premature separation | 6 | 1.9% | 0.4% |
| Sticking | 6 | 1.9% | 1.5% |
| Vibration | 6 | 1.9% | 0.9% |
| Energy output problem | 5 | 1.6% | 0.1% |
| Device slipped | 4 | 1.3% | 0.8% |
| Device stops intermittentlythe device stopped now and then | 4 | 1.3% | 0.8% |
| Loss of powerthe device lost power | 4 | 1.3% | 0.7% |
| Device-device incompatibility | 3 | 1% | 1.3% |
| Failure to power up | 3 | 1% | 0.6% |
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 |
|---|---|---|
| No patient involvement | 9 | 2.9% |
| Not applicable | 3 | 1% |
| Bone fracture(s) | 2 | 0.6% |
| Injurya physical injury | 2 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.3% |
| Tissue damage | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Radiolucent-Drive | Product code HWE | All MAUDE reports |
|---|---|---|---|
| Reports | 308 | 50,440 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 2.9% | 2.3% | 36.2% |
| Classified as malfunction | 97.1% | 97.5% | 62.3% |
| Filed by the manufacturer | 100% | 99.3% | 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 HWE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Small Battery Drive | 2,439 | 0 | 0% |
| Colibri | 1,472 | 0 | 0% |
| Electric Pen Drive 60 000 Rpm | 1,486 | 94 | 0% |
| Sagittal Saw Attachment | 1,505 | 64 | 0% |
| Smartlife Large Aspetic Housing | 1,132 | 2 | 0% |
| Sagittal Saw Attachment Long For Trs | 1,039 | 90 | 0% |
| Quick Coupling For K-Wires | 744 | 28 | 0% |
| Epd 60000 Rpm | 737 | 0 | 0% |
| Air Oscillator | 657 | 0 | 0% |
| Chuck With Key/Drill Speed For Trs | 655 | 94 | 0% |
| Small Battery Drive Colibri | 633 | 0 | 0% |
| Modular Calcar Planer Sml | 515 | 30 | 0% |
| Sagittal Saw Attachment For Trs | 428 | 77 | 0% |
| System 6 Sagittal Saw | 698 | 0 | 0% |
| Unium Modular Handpiece | 403 | 137 | 0% |
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 Radiolucent-Drive reports
How many FDA reports name Radiolucent-Drive?
308 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (97.1%) and injury (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device inoperable (21.4%), mechanical jam (16.6%), noise, audible (15.3%), device operates differently than expected (12%) and complete loss of power (10.1%). 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 Radiolucent-Drive 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.