Reported Reactions

Devices › Guide, surgical, instrument

Device brand name · Guide

130 Deg Aiming Arm F/Trochanteric Fixation Nails: medical device reports filed with FDA

215 reports name it, 2011–2020. Manufacturer given most often on reports: Synthes Brandywine. Product code FZX.

215
device reports naming the brand
0% of all MAUDE reports · about 14 a year
0
reports, 12 months to August 2026
0 in the 12 months before
85.1%
classified as malfunction
82.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

215 medical device reports received by FDA name the brand "130 Deg Aiming Arm F/Trochanteric Fixation Nails" (guide); the manufacturer given most often on reports is Synthes Brandywine; received from January 2011 to November 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (85.1%) and injury (14.9%); across all guide, surgical, instrument reports (product code FZX) death is recorded in 0% and malfunction in 82.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to align (18.1%), device operates differently than expected (16.3%) and break (7%). The patient problems coded most often are no patient involvement, sedation and 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

No report naming 130 Deg Aiming Arm F/Trochanteric Fixation Nails was received in the five years to August 2026; the latest was received in November 2020.

By year received

030602011: 520112012: 720122013: 6020132014: 5520142015: 3620152016: 2320162017: 720172018: 920182019: 1020192020: 32020

Event type and report source

Event type, as classified on the report

Death0%0
Injury14.9%32
Malfunction85.1%183
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%215
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 8,517 reports carrying product code FZX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Failure to align3918.1%5.4%
Device operates differently than expectedthe device behaved unexpectedly3516.3%4.3%
Breakthe device broke157%24%
Failure to adhere or bond136%0.7%
Fitting problem136%2.7%
Positioning problem115.1%1%
Difficult to insertthe device was hard to insert104.7%0.9%
Mechanical jam104.7%3.6%
Device slipped83.7%0.9%
Difficult to position73.3%0.7%
Component missing62.8%0.8%
Detachment of device or device componentpart of the device came off62.8%1.2%
Detachment of device component52.3%0.8%
Bent41.9%1.2%
Disconnection41.9%0.1%
Naturally worn41.9%0.2%
Sticking41.9%0.9%
Failure to advance31.4%0.4%
Component falling20.9%0.3%
Device inoperablethe device could not be used20.9%0.2%

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
No patient involvement146.5%
Sedationdrowsiness from a medicine83.7%
Device embedded in tissue or plaque10.5%

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

In context

Measure130 Deg Aiming Arm F/Trochanteric Fixation NailsProduct code FZXAll MAUDE reports
Reports2158,51726,136,888
Share of that pool—2.5%0%
Classified as death, per 1,000 reports009
Classified as injury14.9%17.3%36.2%
Classified as malfunction85.1%82.5%62.3%
Filed by the manufacturer100%99.4%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 FZX

BrandReportsLatest 12 monthsClassified as death
Blade/Screw Guide Sleeve373400%
Disposable Mixing Bowl And Spatula5772100%
UNK - Guide/Compression/K-Wires213140%
Eea4,9225420.8%
G7 Positioning Guide Rod216320%
Rsp1,36900%
Flexible Silicone Drill Driver206260%
Empowr 3d Knee60700%
Quantum183350.5%
Aiming Arm/ Radiolucent465820%
Anatomage Guide24300%
Biomet33700.3%
Driving Cap497650%
Empowr Hip15000%
Helical Blade Coupling Screw30500%

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 130 Deg Aiming Arm F/Trochanteric Fixation Nails reports

How many FDA reports name 130 Deg Aiming Arm F/Trochanteric Fixation Nails?

215 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (85.1%) and injury (14.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to align (18.1%), device operates differently than expected (16.3%), break (7%), failure to adhere or bond (6%) and fitting problem (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 130 Deg Aiming Arm F/Trochanteric Fixation Nails 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.