Reported Reactions

Devices › Orthopedic manual surgical instrument

Device brand name · Attune instruments resection blocks/devices

Attune Mod Post Saw Cap Sz 3-5: medical device reports filed with FDA

268 reports name it, 2015–2026. Manufacturer given most often on reports: Depuy Ireland - 9616671. Product code LXH.

268
device reports naming the brand
0% of all MAUDE reports · about 24 a year
26
reports, 12 months to August 2026
33 in the 12 months before
100%
classified as malfunction
90.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 268 reports that name the brand "Attune Mod Post Saw Cap Sz 3-5" (attune instruments resection blocks/devices), received between March 2015 and August 2026; the manufacturer given most often on reports is Depuy Ireland - 9616671. Spellings of one product vary from report to report.

26 reports arrived in the 12 months to August 2026, down 21% from 33 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 (100%); across all orthopedic manual surgical instrument reports (product code LXH) death is recorded in 0.1% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (78%), device-device incompatibility (15.3%) and crack (3%). 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

047Sep 2021: 0Oct 2021: 1Nov 2021: 1Dec 2021: 12022Jan 2022: 1Feb 2022: 2Mar 2022: 0Apr 2022: 2May 2022: 1Jun 2022: 1Jul 2022: 0Aug 2022: 1Sep 2022: 4Oct 2022: 2Nov 2022: 3Dec 2022: 12023Jan 2023: 2Feb 2023: 6Mar 2023: 2Apr 2023: 4May 2023: 3Jun 2023: 6Jul 2023: 6Aug 2023: 2Sep 2023: 3Oct 2023: 1Nov 2023: 4Dec 2023: 42024Jan 2024: 1Feb 2024: 5Mar 2024: 3Apr 2024: 2May 2024: 1Jun 2024: 7Jul 2024: 1Aug 2024: 2Sep 2024: 1Oct 2024: 2Nov 2024: 2Dec 2024: 12025Jan 2025: 2Feb 2025: 6Mar 2025: 2Apr 2025: 5May 2025: 3Jun 2025: 4Jul 2025: 3Aug 2025: 2Sep 2025: 3Oct 2025: 7Nov 2025: 5Dec 2025: 32026Jan 2026: 3Feb 2026: 2Mar 2026: 1Apr 2026: 1May 2026: 0Jun 2026: 0Jul 2026: 0Aug 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

023452015: 1820152016: 202017: 1920172018: 182019: 2220192020: 162021: 1320212022: 182023: 4320232024: 282025: 4520252026: 8

Event type and report source

Event type, as classified on the report

Death0%0
Injury0%0
Malfunction100%268
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%268
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 81,663 reports carrying product code LXH. 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 broke20978%43.5%
Device-device incompatibility4115.3%7.5%
Crackthe device cracked83%3.2%
Material deformation41.5%3.9%
Mechanical jam41.5%2.2%
Component missing31.1%1%
Naturally worn31.1%2.4%
Detachment of device or device componentpart of the device came off20.7%2.5%
Insufficient device problem information20.7%1.1%
Scratched material20.7%1.1%
Unintended movement20.7%0.4%
Connection problema connection problem10.4%0.4%
Defective devicethe device was defective10.4%0.3%
Entrapment of device10.4%0.4%
Fitting problem10.4%0.7%
Fracturea broken bone10.4%8.5%
Incorrect measurementthe device measured wrongly10.4%0.1%
Material integrity problema problem with the device material10.4%1.4%
Mechanical problema mechanical problem10.4%1.5%

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.

In context

MeasureAttune Mod Post Saw Cap Sz 3-5Product code LXHAll MAUDE reports
Reports26881,66326,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports019
Classified as injury0%9.2%36.2%
Classified as malfunction100%90.1%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 LXH

BrandReportsLatest 12 monthsClassified as death
Excel T-Handle2,3681500%
Driving Cap/Threaded1,181580%
Orthopedic Manual Surgical Instrument1,14300.2%
Manual Orthopedic Surgical Instrument1,69300.1%
METRx System1,6792670.1%
Glenosphere Inserter Tip8121750%
Baseplate Inserter Rod5611050%
1.5mm Hex Driver Tip, Locking Groove5803320%
R3 Straight Shell Impactor565210%
Driving Cap497650%
5mm Hex Flexible Screwdriver498600.2%
Attune Mod Post Saw Cap Sz 6-8486410%
Exactech57600%
Attune Femoral Impactor3,3281210%
Metrx41530%

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 Mod Post Saw Cap Sz 3-5 reports

How many FDA reports name Attune Mod Post Saw Cap Sz 3-5?

268 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (78%), device-device incompatibility (15.3%), crack (3%), material deformation (1.5%) and mechanical jam (1.5%). 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 Mod Post Saw Cap Sz 3-5 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.