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Device brand name · Screwdriver

Stardrive Screwdriver Shaft T8 55mm: medical device reports filed with FDA

172 reports name it, 2014–2026. Manufacturer given most often on reports: Synthes. Product code HXX.

172
device reports naming the brand
0% of all MAUDE reports · about 14 a year
28
reports, 12 months to August 2026
16 in the 12 months before
98.8%
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 172 reports that name the brand "Stardrive Screwdriver Shaft T8 55mm" (screwdriver), received between July 2014 and August 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.

28 reports arrived in the 12 months to August 2026, up 75% from 16 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 (98.8%) and injury (1.2%); 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 material twisted/bent (60.5%), device-device incompatibility (27.3%) and material deformation (11%). The patient problems coded most often are no patient involvement, foreign body in patient and appropriate clinical signs, symptoms and conditions term/code not available. 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

0510Sep 2021: 4Oct 2021: 1Nov 2021: 1Dec 2021: 32022Jan 2022: 3Feb 2022: 1Mar 2022: 0Apr 2022: 0May 2022: 1Jun 2022: 1Jul 2022: 1Aug 2022: 1Sep 2022: 0Oct 2022: 1Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 4Apr 2023: 1May 2023: 1Jun 2023: 0Jul 2023: 3Aug 2023: 0Sep 2023: 0Oct 2023: 1Nov 2023: 4Dec 2023: 22024Jan 2024: 1Feb 2024: 0Mar 2024: 3Apr 2024: 3May 2024: 4Jun 2024: 2Jul 2024: 6Aug 2024: 1Sep 2024: 2Oct 2024: 0Nov 2024: 0Dec 2024: 32025Jan 2025: 3Feb 2025: 0Mar 2025: 2Apr 2025: 0May 2025: 1Jun 2025: 1Jul 2025: 3Aug 2025: 1Sep 2025: 0Oct 2025: 7Nov 2025: 2Dec 2025: 02026Jan 2026: 0Feb 2026: 1Mar 2026: 1Apr 2026: 2May 2026: 2Jun 2026: 2Jul 2026: 10Aug 2026: 1

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

013252014: 320142016: 42017: 420172018: 102019: 2520192020: 172021: 2020212022: 92023: 1620232024: 252025: 2020252026: 19

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.2%2
Malfunction98.8%170
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%172
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Material twisted/bent10460.5%16%
Device-device incompatibility4727.3%8.6%
Material deformation1911%4.9%
Breakthe device broke63.5%46.7%
Mechanical problema mechanical problem31.7%0.7%
Naturally worn21.2%3.3%
Calibration problem10.6%1.2%
Corrodedthe device corroded10.6%0.1%
Device damaged prior to usethe device was damaged before use10.6%0.2%
Device slipped10.6%0.6%
Entrapment of device10.6%0.9%
Material integrity problema problem with the device material10.6%1.4%

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)ReportsShare
No patient involvement84.7%
Foreign body in patientpart of a device left in the patient21.2%
Appropriate clinical signs, symptoms and conditions term/code not available10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureStardrive Screwdriver Shaft T8 55mmProduct code HXXAll MAUDE reports
Reports17223,40126,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports009
Classified as injury1.2%6.7%36.2%
Classified as malfunction98.8%92.7%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Locking Screwdriver Body967170%
Quickset Taper Hex Scdr Rigid64200%
Manual Orthopedic Surgical Instrument1,69300.1%
CD HORIZON Spinal System9,7876340.3%
Quickset Tprd Hex Scdr U-Joint556120%
Xpdm Quick-Con Si Poly Scwdrvr446130%
Cd Horizon Solera 5 5/6 04781310%
Screwdriver396150%
Quickset Ratchet Scdr Hdl408290%
Stardrive Scrwdrvr Shft/T4 50mm/Self-Retaining/Hxc339160%
Plug Driver308380%
Stardrive Screwdriver Shaft T8 105mm329430%
Cannulated 4 0mm Hexagonal Screwdriver27890%
Hand Piece For Battery Powered Driver558660%
Viper Universal Poly Driver21730%

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 Stardrive Screwdriver Shaft T8 55mm reports

How many FDA reports name Stardrive Screwdriver Shaft T8 55mm?

172 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.

What kinds of events are reported?

malfunction (98.8%) and injury (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

material twisted/bent (60.5%), device-device incompatibility (27.3%), material deformation (11%), break (3.5%) and mechanical problem (1.7%). 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 Stardrive Screwdriver Shaft T8 55mm 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.