Reported Reactions

Devices › Screw, fixation, bone

Device brand name · Screw fixation bone

UNK - Screws: 2.7 mm VA Locking: medical device reports filed with FDA

204 reports name it, 2021–2026. Manufacturer given most often on reports: Synthes. Product code HWC.

204
device reports naming the brand
0% of all MAUDE reports · about 39 a year
22
reports, 12 months to August 2026
28 in the 12 months before
39.7%
classified as malfunction
30.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 204 reports that name the brand "UNK - Screws: 2.7 mm VA Locking" (screw fixation bone), received between April 2021 and July 2026; the manufacturer given most often on reports is Synthes. Spellings of one product vary from report to report.

22 reports arrived in the 12 months to August 2026, down 21% from 28 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 injury (60.3%) and malfunction (39.7%); across all screw, fixation, bone reports (product code HWC) death is recorded in 0.1% and malfunction in 30.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (55.9%), device-device incompatibility (18.6%) and entrapment of device (18.6%). The patient problems coded most often are nonunion/delayed-union bone fracture, foreign body in patient and pain. 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

01224Sep 2021: 0Oct 2021: 7Nov 2021: 0Dec 2021: 22022Jan 2022: 0Feb 2022: 3Mar 2022: 0Apr 2022: 9May 2022: 0Jun 2022: 4Jul 2022: 8Aug 2022: 1Sep 2022: 6Oct 2022: 24Nov 2022: 9Dec 2022: 12023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 7Jun 2023: 1Jul 2023: 15Aug 2023: 7Sep 2023: 0Oct 2023: 1Nov 2023: 6Dec 2023: 22024Jan 2024: 18Feb 2024: 1Mar 2024: 1Apr 2024: 2May 2024: 2Jun 2024: 7Jul 2024: 1Aug 2024: 0Sep 2024: 9Oct 2024: 0Nov 2024: 1Dec 2024: 02025Jan 2025: 0Feb 2025: 1Mar 2025: 2Apr 2025: 5May 2025: 5Jun 2025: 4Jul 2025: 1Aug 2025: 0Sep 2025: 0Oct 2025: 6Nov 2025: 0Dec 2025: 42026Jan 2026: 0Feb 2026: 2Mar 2026: 4Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 6Aug 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

033652021: 1820212022: 6520222023: 3920232024: 4220242025: 2820252026: 122026

Event type and report source

Event type, as classified on the report

Death0%0
Injury60.3%123
Malfunction39.7%81
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%204
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 58,946 reports carrying product code HWC. 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 broke11455.9%26.4%
Device-device incompatibility3818.6%4.1%
Entrapment of device3818.6%1.2%
Material twisted/bent125.9%1.4%
Migrationthe device moved from where it was placed83.9%4.4%
Difficult to advance21%0.4%

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
Nonunion/delayed-union bone fracture4522.1%
Foreign body in patientpart of a device left in the patient2914.2%
Painpain, site not specified199.3%
Muscle/tendon damage83.9%
Failure of implant73.4%
Impaired healingslow healing73.4%
Appropriate clinical signs, symptoms and conditions term/code not available62.9%
Discomfortdiscomfort52.5%
Falla fall42%
Malunion of bone42%

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

In context

MeasureUNK - Screws: 2.7 mm VA LockingProduct code HWCAll MAUDE reports
Reports20458,94626,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports019
Classified as injury60.3%67.2%36.2%
Classified as malfunction39.7%30.8%62.3%
Filed by the manufacturer100%97.3%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 HWC

BrandReportsLatest 12 monthsClassified as death
UNK - Screws: Trauma3,5762880%
UNK - Screws: Locking2,331980%
Unk - Screws Cortex889160%
Unknown Screw1,2221560%
Screw64700%
UNK - Screws: Nail Distal Locking444120.2%
Unknown Screws652231.7%
UNK - Screws: CMF4102800%
UNK - Screws: Locking: Trauma276340%
Unk - Screws 3 5 Mm Cortex220330%
Unk - Screws Nail Locking211190%
Unk - Screws Cannulated19090.5%
Unk - Screws25600%
Locking Screw24130%
Ni32,9391,5871.8%

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 UNK - Screws: 2.7 mm VA Locking reports

How many FDA reports name UNK - Screws: 2.7 mm VA Locking?

204 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 22 in the latest 12 months.

What kinds of events are reported?

injury (60.3%) and malfunction (39.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (55.9%), device-device incompatibility (18.6%), entrapment of device (18.6%), material twisted/bent (5.9%) and migration (3.9%). 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 UNK - Screws: 2.7 mm VA Locking 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.