Reported Reactions

Devices › Orthopedic manual surgical instrument

Device brand name · Attune instruments resection blocks/devices

Attune Mod Post Saw Cap Sz 6-8: medical device reports filed with FDA

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

486
device reports naming the brand
0% of all MAUDE reports · about 42 a year
41
reports, 12 months to August 2026
51 in the 12 months before
99.8%
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 486 reports that name the brand "Attune Mod Post Saw Cap Sz 6-8" (attune instruments resection blocks/devices), received between January 2015 and May 2026; the manufacturer given most often on reports is Depuy Ireland - 9616671. Spellings of one product vary from report to report.

41 reports arrived in the 12 months to August 2026, down 20% from 51 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 (99.8%) and injury (0.2%); 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 (86.8%), device-device incompatibility (16.7%) and naturally worn (1.4%). The patient problems coded most often are not applicable 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

0510Sep 2021: 7Oct 2021: 4Nov 2021: 3Dec 2021: 52022Jan 2022: 1Feb 2022: 3Mar 2022: 7Apr 2022: 7May 2022: 2Jun 2022: 2Jul 2022: 0Aug 2022: 3Sep 2022: 2Oct 2022: 7Nov 2022: 1Dec 2022: 62023Jan 2023: 4Feb 2023: 6Mar 2023: 3Apr 2023: 5May 2023: 5Jun 2023: 3Jul 2023: 9Aug 2023: 1Sep 2023: 3Oct 2023: 1Nov 2023: 7Dec 2023: 12024Jan 2024: 2Feb 2024: 5Mar 2024: 4Apr 2024: 3May 2024: 4Jun 2024: 6Jul 2024: 3Aug 2024: 6Sep 2024: 2Oct 2024: 10Nov 2024: 4Dec 2024: 42025Jan 2025: 6Feb 2025: 6Mar 2025: 4Apr 2025: 4May 2025: 3Jun 2025: 3Jul 2025: 4Aug 2025: 1Sep 2025: 4Oct 2025: 9Nov 2025: 5Dec 2025: 82026Jan 2026: 6Feb 2026: 2Mar 2026: 4Apr 2026: 2May 2026: 1Jun 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

029572015: 2720152016: 422017: 5520172018: 342019: 2720192020: 402021: 4720212022: 412023: 4820232024: 532025: 5720252026: 15

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.2%1
Malfunction99.8%485
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%486
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 broke42286.8%43.5%
Device-device incompatibility8116.7%7.5%
Naturally worn71.4%2.4%
Scratched material40.8%1.1%
Detachment of device or device componentpart of the device came off30.6%2.5%
Material deformation30.6%3.9%
Material twisted/bent30.6%2.3%
Component missing20.4%1%
Connection problema connection problem20.4%0.4%
Crackthe device cracked20.4%3.2%
Corrodedthe device corroded10.2%0.9%
Detachment of device component10.2%2.7%
Device damaged prior to usethe device was damaged before use10.2%0.1%
Entrapment of device10.2%0.4%
Fitting problem10.2%0.7%
Fracturea broken bone10.2%8.5%
Incorrect measurementthe device measured wrongly10.2%0.1%
Material fragmentation10.2%1.4%
Mechanical jam10.2%2.2%
Mechanical problema mechanical problem10.2%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.

Patient problems coded

Patient problem (FDA code)ReportsShare
Not applicable40.8%
Foreign body in patientpart of a device left in the patient10.2%

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

In context

MeasureAttune Mod Post Saw Cap Sz 6-8Product code LXHAll MAUDE reports
Reports48681,66326,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports019
Classified as injury0.2%9.2%36.2%
Classified as malfunction99.8%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%
Exactech57600%
Attune Femoral Impactor3,3281210%
Metrx41530%
Cor/Tri Ant Stem Insert Shaft1,207500%

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 6-8 reports

How many FDA reports name Attune Mod Post Saw Cap Sz 6-8?

486 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 41 in the latest 12 months.

What kinds of events are reported?

malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (86.8%), device-device incompatibility (16.7%), naturally worn (1.4%), scratched material (0.8%) and detachment of device or device component (0.6%). 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 6-8 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.