Guide, surgical, instrument: medical device reports filed with FDA

8,517 reports carry this product code, 1996–2026; 28 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

8,517
reports with this product code: 0% of all MAUDE reports; 532
reports, 12 months to August 2026: 736 in the 12 months before; 82.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code FZX is FDA's classification for "Guide, surgical, instrument" (general, Plastic Surgery panel), a class 1 device. 8,517 medical device reports carry this product code, 0% of the MAUDE database, from October 1996 to August 2026.

532 reports arrived in the 12 months to August 2026, down 28% from 736 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 (82.5%), injury (17.3%) and other (0.1%). 28 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Blade/Screw Guide Sleeve	372	40	0%	96%
130 Deg Aiming Arm F/Trochanteric Fixation Nails	198	0	0%	85.1%
Disposable Mixing Bowl And Spatula	111	210	0%	99%
UNK - Guide/Compression/K-Wires	44	14	0%	70%
Eea	15	542	0.8%	58.4%
G7 Positioning Guide Rod	12	32	0%	97.2%
Rsp	9	0	0%	1.7%
Flexible Silicone Drill Driver	4	26	0%	98.1%
Empowr 3d Knee	3	0	0%	0%
Quantum	2	35	0.5%	66.7%
Aiming Arm/ Radiolucent	1	82	0%	100%
Anatomage Guide	1	0	0%	4.5%
Biomet	1	0	0.3%	20.5%
Driving Cap	1	65	0%	99.2%
Empowr Hip	1	0	0%	1.3%
Helical Blade Coupling Screw	1	0	0%	90.5%
Imp Tsv Mcol Mg 3 7mm 10m	1	65	0%	4%
Impl Tapered Scr-V Sbm 3 7mm 3 5mm 13mm	1	103	0%	5.7%
Quickset 1pc Flex Drill Bit 25	1	158	0%	99.2%
Rsp Shoulder	1	0	0%	1.2%
Standard Insertion Handle	1	0	0%	81.3%
Synthes	1	0	0.6%	36.4%
Taperfill Hip	1	0	0%	0.5%
Tear Drop Guide Wire 3 0 Mm Diameter 100 Cm Length	1	0	0%	99.4%
UNK - Implant	1	80	0%	16.2%
Unknown Other Products	1	0	0%	87.6%
Z S G M Cutter 1 5 1 Ratio Caution Sharp	1	17	0%	99.7%
Z S G M Cutter 2 1 Ratio Caution Sharp	1	6	0%	99.5%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Synthes	2,474	29%
Wrights Lane Synthes USA Products	1,229	14.4%
Encore Medical L P	590	6.9%
Synthes Brandywine	368	4.3%
Synthes Hagendorf	353	4.1%
Synthes Monument	291	3.4%
Oberdorf Synthes Produktions	266	3.1%
Synthes Bettlach	248	2.9%
Synthes USA	158	1.9%
Depuy Mitek US	41	0.5%
Biomet Orthopedics	22	0.3%
Wright Medical Technology	21	0.2%
Depuy Mitek	19	0.2%
Depuy Spine	15	0.2%
Synthes Elmira	15	0.2%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0%4

Injury17.3%1,473

Malfunction82.5%7,026

Other0.1%7

Not given0.1%7

Who filed

Manufacturer report99.4%8,468

Voluntary report0.3%24

User facility report0%0

Distributor report0%1

Not given0.3%24

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device-device incompatibility	2,271	26.7%
Breakthe device broke	2,047	24%
Material deformation	576	6.8%
Failure to align	458	5.4%
Device operates differently than expectedthe device behaved unexpectedly	367	4.3%
Material twisted/bent	357	4.2%
Mechanical jam	309	3.6%
Fracturea broken bone	289	3.4%
Fitting problem	228	2.7%
Unstable	161	1.9%
Bent	106	1.2%
Detachment of device or device componentpart of the device came off	104	1.2%
Device contaminated during manufacture or shipping	97	1.1%
Entrapment of device	92	1.1%
Material integrity problema problem with the device material	90	1.1%
Positioning problem	81	1%
Sticking	79	0.9%
Difficult to insertthe device was hard to insert	78	0.9%
Material fragmentation	78	0.9%
Device slipped	77	0.9%

Questions about guide, surgical, instrument reports

What is product code FZX?

FDA's classification code for "Guide, surgical, instrument", class 1, reviewed by the general, Plastic Surgery panel. Every device report carries the product code of the device involved.

How many reports carry this code?

8,517 reports through August 2026, 532 of them in the latest 12 months.

Which brands appear most often?

Blade/Screw Guide Sleeve (372), 130 Deg Aiming Arm F/Trochanteric Fixation Nails (198), Disposable Mixing Bowl And Spatula (111), UNK - Guide/Compression/K-Wires (44) and Eea (15). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.