Reported Reactions

Devices › Orthopedic manual surgical instrument

Device brand name · Fixation pin

UNK Fixation Pin: medical device reports filed with FDA

189 reports name it, 2019–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LXH.

189
device reports naming the brand
0% of all MAUDE reports · about 28 a year
45
reports, 12 months to August 2026
30 in the 12 months before
98.9%
classified as malfunction
90.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

189 medical device reports received by FDA name the brand "UNK Fixation Pin" (fixation pin); the manufacturer given most often on reports is Depuy Orthopaedics US; received from October 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

45 reports arrived in the 12 months to August 2026, up 50% from 30 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 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 device-device incompatibility (79.4%), break (27%) and material deformation (5.3%). The patient problems coded most often are bone fracture(s) 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: 2Oct 2021: 1Nov 2021: 0Dec 2021: 32022Jan 2022: 5Feb 2022: 2Mar 2022: 4Apr 2022: 2May 2022: 2Jun 2022: 1Jul 2022: 0Aug 2022: 0Sep 2022: 1Oct 2022: 1Nov 2022: 1Dec 2022: 32023Jan 2023: 2Feb 2023: 1Mar 2023: 8Apr 2023: 1May 2023: 7Jun 2023: 5Jul 2023: 0Aug 2023: 4Sep 2023: 1Oct 2023: 1Nov 2023: 1Dec 2023: 12024Jan 2024: 3Feb 2024: 1Mar 2024: 6Apr 2024: 2May 2024: 1Jun 2024: 2Jul 2024: 4Aug 2024: 2Sep 2024: 3Oct 2024: 1Nov 2024: 5Dec 2024: 32025Jan 2025: 2Feb 2025: 2Mar 2025: 5Apr 2025: 1May 2025: 3Jun 2025: 1Jul 2025: 3Aug 2025: 1Sep 2025: 4Oct 2025: 4Nov 2025: 3Dec 2025: 32026Jan 2026: 1Feb 2026: 2Mar 2026: 10Apr 2026: 3May 2026: 2Jun 2026: 4Jul 2026: 4Aug 2026: 5

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

017332019: 420192020: 1520202021: 2020212022: 2220222023: 3220232024: 3320242025: 3220252026: 312026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.1%2
Malfunction98.9%187
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%189
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
Device-device incompatibility15079.4%7.5%
Breakthe device broke5127%43.5%
Material deformation105.3%3.9%
Unstable63.2%0.1%
Mechanical jam42.1%2.2%
Improper or incorrect procedure or method21.1%0.2%
Naturally worn21.1%2.4%
Physical resistance/sticking21.1%1.1%
Connection problema connection problem10.5%0.4%
Entrapment of device10.5%0.4%
Unintended movement10.5%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
Bone fracture(s)10.5%
Foreign body in patientpart of a device left in the patient10.5%

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

In context

MeasureUNK Fixation PinProduct code LXHAll MAUDE reports
Reports18981,66326,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports019
Classified as injury1.1%9.2%36.2%
Classified as malfunction98.9%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 UNK Fixation Pin reports

How many FDA reports name UNK Fixation Pin?

189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 45 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?

device-device incompatibility (79.4%), break (27%), material deformation (5.3%), unstable (3.2%) and mechanical jam (2.1%). 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 Fixation Pin 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.