Reported Reactions

Devices › Instrument, compression

Device brand name · Attune instruments patella handle/clamps

Attune Patella Compression Rng: medical device reports filed with FDA

179 reports name it, 2016–2025. Manufacturer given most often on reports: Depuy Ireland - 9616671. Product code HWN.

179
device reports naming the brand
0% of all MAUDE reports · about 17 a year
7
reports, 12 months to August 2026
22 in the 12 months before
98.9%
classified as malfunction
96.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 179 reports that name the brand "Attune Patella Compression Rng" (attune instruments patella handle/clamps), received between March 2016 and November 2025; the manufacturer given most often on reports is Depuy Ireland - 9616671. Spellings of one product vary from report to report.

7 reports arrived in the 12 months to August 2026, down 68% from 22 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 (98.9%) and injury (1.1%); across all instrument, compression reports (product code HWN) death is recorded in 0% and malfunction in 96.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (46.9%), crack (20.1%) and naturally worn (10.1%). The patient problems coded most often are device embedded in tissue or plaque. 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

048Sep 2021: 2Oct 2021: 2Nov 2021: 2Dec 2021: 12022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 2May 2022: 1Jun 2022: 1Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 1Nov 2022: 1Dec 2022: 12023Jan 2023: 5Feb 2023: 1Mar 2023: 1Apr 2023: 0May 2023: 2Jun 2023: 0Jul 2023: 2Aug 2023: 0Sep 2023: 4Oct 2023: 4Nov 2023: 3Dec 2023: 12024Jan 2024: 1Feb 2024: 1Mar 2024: 3Apr 2024: 0May 2024: 3Jun 2024: 1Jul 2024: 2Aug 2024: 8Sep 2024: 4Oct 2024: 2Nov 2024: 0Dec 2024: 12025Jan 2025: 6Feb 2025: 1Mar 2025: 0Apr 2025: 6May 2025: 0Jun 2025: 1Jul 2025: 1Aug 2025: 0Sep 2025: 1Oct 2025: 4Nov 2025: 2Dec 2025: 02026Jan 2026: 0Feb 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

013262016: 1620162017: 1720172018: 920182019: 1820192020: 1620202021: 2520212022: 720222023: 2320232024: 2620242025: 222025

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.1%2
Malfunction98.9%177
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%179
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 839 reports carrying product code HWN. 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 broke8446.9%50.3%
Crackthe device cracked3620.1%7.4%
Naturally worn1810.1%5.1%
Device-device incompatibility147.8%13.9%
Detachment of device or device componentpart of the device came off95%2.3%
Material twisted/bent84.5%5.4%
Scratched material84.5%1.3%
Material deformation42.2%5.5%
Component missing31.7%1.2%
Fitting problem31.7%0.5%
Torn material31.7%1.1%
Contamination /decontamination problem21.1%1.1%
Corrodedthe device corroded21.1%0.6%
Connection problema connection problem10.6%0.2%
Device reprocessing problem10.6%0.1%
Insufficient device problem information10.6%0.1%
Material discolored10.6%0.4%
Material integrity problema problem with the device material10.6%0.1%
Material split, cut or torn10.6%0.2%
Mechanical jam10.6%2.3%

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
Device embedded in tissue or plaque10.6%

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

In context

MeasureAttune Patella Compression RngProduct code HWNAll MAUDE reports
Reports17983926,136,888
Share of that pool—21.3%0%
Classified as death, per 1,000 reports009
Classified as injury1.1%3.1%36.2%
Classified as malfunction98.9%96.5%62.3%
Filed by the manufacturer100%99.5%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 HWN

BrandReportsLatest 12 monthsClassified as death
Attune Patella Drill Clamp469500%
Scd 700 Compression System-Us16900%

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 Attune Patella Compression Rng reports

How many FDA reports name Attune Patella Compression Rng?

179 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.

What kinds of events are reported?

malfunction (98.9%) and injury (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (46.9%), crack (20.1%), naturally worn (10.1%), device-device incompatibility (7.8%) and detachment of device or device component (5%). 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 Attune Patella Compression Rng 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.