Device brand name · Air dermatome handpiece
Air Dermatome Handpiece: medical device reports filed with FDA
511 reports name it, 2009–2015. Manufacturer given most often on reports: Zimmer Surgical. Product code GFD.
- 511
- device reports naming the brand
- 0% of all MAUDE reports · about 30 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 67.3%
- classified as malfunction
- 79.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
511 medical device reports received by FDA name the brand "Air Dermatome Handpiece" (air dermatome handpiece); the manufacturer given most often on reports is Zimmer Surgical; received from June 2009 to November 2015. 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 (67.3%), injury (32.5%) and other (0.2%); across all dermatome reports (product code GFD) death is recorded in 0% and malfunction in 79.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (51.1%), failure to cut (11.4%) and device inoperable (8.4%). The patient problems coded most often are tissue damage, laceration(s) and no patient involvement. 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 Air Dermatome Handpiece was received in the five years to August 2026; the latest was received in November 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 8,195 reports carrying product code GFD. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 261 | 51.1% | 14% |
| Failure to cut | 58 | 11.4% | 26.9% |
| Device inoperablethe device could not be used | 43 | 8.4% | 2% |
| Mechanical problema mechanical problem | 18 | 3.5% | 3.1% |
| Breakthe device broke | 14 | 2.7% | 2.2% |
| Air leak | 13 | 2.5% | 0.6% |
| Failure to power up | 13 | 2.5% | 2.4% |
| Sticking | 11 | 2.2% | 0.6% |
| Improper or incorrect procedure or method | 10 | 2% | 0.6% |
| Noise, audible | 9 | 1.8% | 2.7% |
| Device stops intermittentlythe device stopped now and then | 8 | 1.6% | 0.7% |
| Failure to shut off | 8 | 1.6% | 0.2% |
| Leak/splashthe device leaked | 7 | 1.4% | 0.2% |
| Power problem | 7 | 1.4% | 6.2% |
| Insufficient device problem information | 6 | 1.2% | 1.7% |
| Loss of powerthe device lost power | 6 | 1.2% | 1.8% |
| Positioning problem | 6 | 1.2% | 0.6% |
| Device slipped | 5 | 1% | 0.3% |
| Hole in material | 5 | 1% | 0.1% |
| Mechanics altered | 5 | 1% | 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) | Reports | Share |
|---|---|---|
| Tissue damage | 89 | 17.4% |
| Laceration(s) | 31 | 6.1% |
| No patient involvement | 14 | 2.7% |
| Injurya physical injury | 10 | 2% |
| Skin tears | 10 | 2% |
| Skin erosion | 2 | 0.4% |
| Blood loss | 1 | 0.2% |
| Extubate | 1 | 0.2% |
| Failure of implant | 1 | 0.2% |
| Failure to anastomose | 1 | 0.2% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.2% |
| Hearing loss | 1 | 0.2% |
| Hemorrhage/blood loss/bleeding | 1 | 0.2% |
| Intimal dissection | 1 | 0.2% |
| Perforation | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Air Dermatome Handpiece | Product code GFD | All MAUDE reports |
|---|---|---|---|
| Reports | 511 | 8,195 | 26,136,888 |
| Share of that pool | — | 6.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 32.5% | 19.5% | 36.2% |
| Classified as malfunction | 67.3% | 79.4% | 62.3% |
| Filed by the manufacturer | 99.8% | 96.4% | 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 GFD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Zimmer Air Dermatome | 2,687 | 372 | 0% |
| Handpiece Electric Dermatome | 1,825 | 174 | 0% |
| Dermatome AN Handpiece | 446 | 117 | 0% |
| Electric Dermatome Handpiece | 265 | 0 | 0% |
| Air Dermatome Kit | 205 | 0 | 0% |
| Padgett Model S Slimline Electric Dermatome | 247 | 0 | 0% |
| Dermatome Blades | 170 | 5 | 0% |
| Zimmer Skin Graft Mesher | 3,463 | 285 | 0% |
| Zimmer | 1,159 | 0 | 2.8% |
| Fan Spray Kit | 850 | 173 | 0% |
| Hip Kit | 652 | 135 | 0% |
| Universal Hose 10 | 153 | 0 | 0% |
| Z S G M Cutter 1 5 1 Ratio Caution Sharp | 342 | 17 | 0% |
| Z S G M Cutter 2 1 Ratio Caution Sharp | 220 | 6 | 0% |
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 Air Dermatome Handpiece reports
How many FDA reports name Air Dermatome Handpiece?
511 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 (67.3%), injury (32.5%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (51.1%), failure to cut (11.4%), device inoperable (8.4%), mechanical problem (3.5%) and break (2.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Air Dermatome Handpiece 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.