Dermatome: medical device reports filed with FDA

8,195 reports carry this product code, 1992–2026; 15 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.

8,195
reports with this product code: 0% of all MAUDE reports; 742
reports, 12 months to August 2026: 805 in the 12 months before; 79.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code GFD is FDA's classification for "Dermatome" (general, Plastic Surgery panel), a class 1 device. 8,195 medical device reports carry this product code, 0% of the MAUDE database, from February 1992 to August 2026.

742 reports arrived in the 12 months to August 2026, close to the 805 of 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 (79.4%), injury (19.5%) and other (0.8%). 15 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
Zimmer Air Dermatome	2,679	372	0%	79.6%
Handpiece Electric Dermatome	1,821	174	0%	92.6%
Air Dermatome Handpiece	502	0	0%	67.3%
Dermatome AN Handpiece	445	117	0%	87.2%
Electric Dermatome Handpiece	262	0	0%	74%
Air Dermatome Kit	205	0	0%	83.4%
Padgett Model S Slimline Electric Dermatome	198	0	0%	75.7%
Dermatome Blades	169	5	0%	48.2%
Zimmer Skin Graft Mesher	167	285	0%	96%
Zimmer	17	0	2.8%	17.2%
Fan Spray Kit	4	173	0%	98.2%
Hip Kit	1	135	0%	96.8%
Universal Hose 10	1	0	0%	99.3%
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
Zimmer Surgical	6,754	82.4%
Integra Lifesciences Oh/USA	262	3.2%
Integra Lifesciences	116	1.4%
Zimmer	18	0.2%
Aesculap	13	0.2%
Sterilmed	2	0%
Arthrocare	1	0%
Stryker Instruments	1	0%
Stryker Instruments-Kalamazoo	1	0%

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%1

Injury19.5%1,597

Malfunction79.4%6,503

Other0.8%64

Not given0.4%30

Who filed

Manufacturer report96.4%7,902

Voluntary report1.3%104

User facility report0%0

Distributor report0.1%8

Not given2.2%181

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

Device problems coded

Device problem (FDA code)	Reports	Share
Failure to cut	2,207	26.9%
Device operates differently than expectedthe device behaved unexpectedly	1,147	14%
Unstable	540	6.6%
Power problem	505	6.2%
Gas/air leak	404	4.9%
Patient device interaction problem	382	4.7%
Intermittent loss of power	298	3.6%
Calibration problem	258	3.1%
Mechanical problema mechanical problem	250	3.1%
Noise, audible	221	2.7%
Failure to power up	198	2.4%
Material deformation	193	2.4%
Material frayed	186	2.3%
Naturally worn	184	2.2%
Breakthe device broke	181	2.2%
Device inoperablethe device could not be used	161	2%
Component missing	155	1.9%
Loss of powerthe device lost power	146	1.8%
Insufficient device problem information	139	1.7%
Output below specifications	129	1.6%

Questions about dermatome reports

What is product code GFD?

FDA's classification code for "Dermatome", 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?

8,195 reports through August 2026, 742 of them in the latest 12 months.

Which brands appear most often?

Zimmer Air Dermatome (2,679), Handpiece Electric Dermatome (1,821), Air Dermatome Handpiece (502), Dermatome AN Handpiece (445) and Electric Dermatome Handpiece (262). 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.