Blade, saw, general & plastic surgery, surgical: medical device reports filed with FDA

5,883 reports carry this product code, 1992–2026; 23 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.

5,883
reports with this product code: 0% of all MAUDE reports; 389
reports, 12 months to August 2026: 437 in the 12 months before; 90.9%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code GFA is FDA's classification for "Blade, saw, general & plastic surgery, surgical" (general, Plastic Surgery panel), a class 1 device. 5,883 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

389 reports arrived in the 12 months to August 2026, down 11% from 437 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 (90.9%), injury (8.5%) and other (0.2%). 23 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
Unknown_InstrumentstIre_Product	351	123	0%	97.4%
Universal Oscillating Saw Attachment	178	0	0%	98.3%
Sagittal Blade	109	0	0%	89.6%
Oscillating Saw Atch Large With Key	75	12	0%	100%
Universal Modular Electric/Battery Double	60	0	0%	100%
2 5mm Drill Bit/Qc/Gold/110mm	36	14	0%	74.1%
Conmed	29	89	0.2%	65.6%
4 0mm Aggressive Plus Cutter Formula 5bx	28	0	0%	94.7%
Micro Sagittal Saw	8	0	0%	99.4%
Unknown Instruments Product	8	23	0.8%	80.5%
Micro Oscillating Saw	7	0	0%	97.1%
Unknown_Endoscopy_Product	7	22	0.4%	69.7%
Stryker	6	5	1.3%	46.3%
Sagittal Saw Attachment	5	64	0%	99.3%
Air Dermatome Handpiece	3	0	0%	67.3%
Oscill-Saw-Attachm F/532 001 532 010 532	2	0	0%	99.4%
Zimmer Skin Graft Mesher	2	285	0%	96%
Dermatome Blades	1	5	0%	48.2%
Discovery Elbow	1	0	0%	1.1%
Power Drive	1	0	0%	99.8%
Profix	1	0	0%	0.1%
System 6 Sagittal Saw	1	0	0%	99.1%
Unknown Cork Product	1	0	0%	6.6%

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
Stryker Instruments-A Division Of Stryker	841	14.3%
Stryker Endoscopy-San Jose	586	10%
Stryker Instruments-Kalamazoo	479	8.1%
Terumo Cardiovascular Systems	463	7.9%
Zimmer Surgical	450	7.6%
Stryker Ireland	432	7.3%
Depuy Synthes Power Tools	204	3.5%
Conmed	118	2%
Synthes Oberdorf	108	1.8%
Stryker Instruments	89	1.5%
Terumo Cardiovascular System	87	1.5%
Depuy Synthes Products	63	1.1%
Conmed Linvatec	54	0.9%
Arthrex	34	0.6%
Aesculap	33	0.6%

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%2

Injury8.5%499

Malfunction90.9%5,350

Other0.2%14

Not given0.3%18

Who filed

Manufacturer report94.8%5,580

Voluntary report2%116

User facility report0%0

Distributor report0.2%9

Not given3%178

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

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	1,791	30.4%
Fracturea broken bone	1,065	18.1%
Material fragmentation	475	8.1%
Device operates differently than expectedthe device behaved unexpectedly	365	6.2%
Mechanical jam	240	4.1%
Device inoperablethe device could not be used	184	3.1%
Detachment of device component	144	2.4%
Complete loss of power	137	2.3%
Bent	104	1.8%
Tear, rip or hole in device packaging	101	1.7%
Delivered as unsterile product	93	1.6%
Overheating of device	79	1.3%
Metal shedding debris	72	1.2%
Dull, blunt	64	1.1%
Component falling	60	1%
Component missing	59	1%
Noise, audible	57	1%
Mechanical problema mechanical problem	56	1%
Smoking	56	1%
Device contaminated during manufacture or shipping	46	0.8%

Questions about blade, saw, general & plastic surgery, surgical reports

What is product code GFA?

FDA's classification code for "Blade, saw, general & plastic surgery, surgical", 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?

5,883 reports through August 2026, 389 of them in the latest 12 months.

Which brands appear most often?

Unknown_InstrumentstIre_Product (351), Universal Oscillating Saw Attachment (178), Sagittal Blade (109), Oscillating Saw Atch Large With Key (75) and Universal Modular Electric/Battery Double (60). 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.