Device brand name · Screwdriver
Screwdriver: medical device reports filed with FDA
396 reports name it, 1997–2026. Manufacturer given most often on reports: Medtronic Sofamor Danek USA. Product code HXX.
- 396
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 15
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87.6%
- classified as malfunction
- 92.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 396 reports that name the brand "Screwdriver" (screwdriver), received between July 1997 and August 2026; the manufacturer given most often on reports is Medtronic Sofamor Danek USA. Spellings of one product vary from report to report.
15 reports arrived in the 12 months to August 2026, with none 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 (87.6%) and injury (12.1%); across all screwdriver reports (product code HXX) death is recorded in 0% and malfunction in 92.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (77%), material deformation (3.3%) and detachment of device component (2%). The patient problems coded most often are device embedded in tissue or plaque, no patient involvement and foreign body, removal of. 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 23,401 reports carrying product code HXX. 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 | 305 | 77% | 46.7% |
| Material deformation | 13 | 3.3% | 4.9% |
| Detachment of device component | 8 | 2% | 2.1% |
| Material twisted/bent | 8 | 2% | 16% |
| Detachment of device or device componentpart of the device came off | 5 | 1.3% | 1.1% |
| Difficult to removethe device was hard to remove | 5 | 1.3% | 1% |
| Mechanical problema mechanical problem | 5 | 1.3% | 0.7% |
| Device, removal of (non-implant) | 4 | 1% | 0.4% |
| Material integrity problema problem with the device material | 4 | 1% | 1.4% |
| Tip breakage | 4 | 1% | 1.9% |
| Compatibility problem | 3 | 0.8% | 0.4% |
| Device-device incompatibility | 3 | 0.8% | 8.6% |
| Fracturea broken bone | 3 | 0.8% | 6.9% |
| Device, or device fragments remain in patient | 2 | 0.5% | 0.9% |
| Naturally worn | 2 | 0.5% | 3.3% |
| Replace | 2 | 0.5% | 0.6% |
| Component falling | 1 | 0.3% | 0.3% |
| Component incompatible | 1 | 0.3% | 0% |
| Component(s), broken | 1 | 0.3% | 0.2% |
| Degraded | 1 | 0.3% | 0.1% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 42 | 10.6% |
| No patient involvement | 6 | 1.5% |
| Foreign body, removal of | 4 | 1% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.5% |
| Nonresorbable materials, unretrieved in body | 2 | 0.5% |
| Blood loss | 1 | 0.3% |
| Dysphagia/ odynophagia | 1 | 0.3% |
| Injurya physical injury | 1 | 0.3% |
| Paralysis | 1 | 0.3% |
| Therapy/non-surgical treatment, additional | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Screwdriver | Product code HXX | All MAUDE reports |
|---|---|---|---|
| Reports | 396 | 23,401 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 12.1% | 6.7% | 36.2% |
| Classified as malfunction | 87.6% | 92.7% | 62.3% |
| Filed by the manufacturer | 97.2% | 98.6% | 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 HXX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Locking Screwdriver Body | 967 | 17 | 0% |
| Quickset Taper Hex Scdr Rigid | 642 | 0 | 0% |
| Manual Orthopedic Surgical Instrument | 1,693 | 0 | 0.1% |
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Quickset Tprd Hex Scdr U-Joint | 556 | 12 | 0% |
| Xpdm Quick-Con Si Poly Scwdrvr | 446 | 13 | 0% |
| Cd Horizon Solera 5 5/6 0 | 478 | 131 | 0% |
| Quickset Ratchet Scdr Hdl | 408 | 29 | 0% |
| Stardrive Scrwdrvr Shft/T4 50mm/Self-Retaining/Hxc | 339 | 16 | 0% |
| Plug Driver | 308 | 38 | 0% |
| Stardrive Screwdriver Shaft T8 105mm | 329 | 43 | 0% |
| Cannulated 4 0mm Hexagonal Screwdriver | 278 | 9 | 0% |
| Hand Piece For Battery Powered Driver | 558 | 66 | 0% |
| Viper Universal Poly Driver | 217 | 3 | 0% |
| Quickset Tprd Hex Scdr Cardan | 242 | 2 | 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 Screwdriver reports
How many FDA reports name Screwdriver?
396 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
malfunction (87.6%) and injury (12.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (77%), material deformation (3.3%), detachment of device component (2%), material twisted/bent (2%) and detachment of device or device component (1.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.2%) and voluntary reports (1.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Screwdriver 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.