Reported Reactions

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Device brand name · Screwdrivers

T25 Stardrive Shaft F/Matrix Long: medical device reports filed with FDA

154 reports name it, 2012–2026. Manufacturer given most often on reports: Synthes Monument. Product code HXX.

154
device reports naming the brand
0% of all MAUDE reports · about 11 a year
6
reports, 12 months to August 2026
7 in the 12 months before
94.2%
classified as malfunction
92.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

154 medical device reports received by FDA name the brand "T25 Stardrive Shaft F/Matrix Long" (screwdrivers); the manufacturer given most often on reports is Synthes Monument; received from October 2012 to January 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

6 reports arrived in the 12 months to August 2026, down 14% from 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 (94.2%) and injury (5.8%); 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 (27.3%), dull, blunt (14.9%) and material twisted/bent (11.7%). The patient problems coded most often are no patient involvement, device embedded in tissue or plaque and foreign body in patient. 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

024Sep 2021: 1Oct 2021: 0Nov 2021: 1Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 4Apr 2023: 1May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 2Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 2Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 4Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 3Sep 2025: 0Oct 2025: 0Nov 2025: 3Dec 2025: 02026Jan 2026: 3Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

014282012: 620122013: 282014: 1520142015: 92016: 1320162017: 232018: 1220182019: 152020: 420202021: 72023: 720232024: 62025: 620252026: 3

Event type and report source

Event type, as classified on the report

Death0%0
Injury5.8%9
Malfunction94.2%145
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%154
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
Breakthe device broke4227.3%46.7%
Dull, blunt2314.9%1.1%
Material twisted/bent1811.7%16%
Detachment of device component85.2%2.1%
Bent53.2%1.5%
Material integrity problema problem with the device material53.2%1.4%
Naturally worn53.2%3.3%
Peeled/delaminated53.2%0.2%
Device operates differently than expectedthe device behaved unexpectedly42.6%1.2%
Difficult to removethe device was hard to remove42.6%1%
Material deformation31.9%4.9%
Material fragmentation31.9%1.3%
Sticking31.9%0.5%
Component falling21.3%0.3%
Detachment of device or device componentpart of the device came off21.3%1.1%
Device slipped21.3%0.6%
Device-device incompatibility21.3%8.6%
Loose or intermittent connection21.3%0.2%
Crackthe device cracked10.6%0.9%
Device damaged by another device10.6%0%

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 involvement1610.4%
Device embedded in tissue or plaque21.3%
Foreign body in patientpart of a device left in the patient10.6%
Laceration(s)10.6%
Painpain, site not specified10.6%
Sedationdrowsiness from a medicine10.6%

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

In context

MeasureT25 Stardrive Shaft F/Matrix LongProduct code HXXAll MAUDE reports
Reports15423,40126,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports009
Classified as injury5.8%6.7%36.2%
Classified as malfunction94.2%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 T25 Stardrive Shaft F/Matrix Long reports

How many FDA reports name T25 Stardrive Shaft F/Matrix Long?

154 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 6 in the latest 12 months.

What kinds of events are reported?

malfunction (94.2%) and injury (5.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (27.3%), dull, blunt (14.9%), material twisted/bent (11.7%), detachment of device component (5.2%) and bent (3.2%). 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 T25 Stardrive Shaft F/Matrix Long 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.