Devices › Expander, surgical, skin graft
Device brand name · Expander surgical skin graft
Zimmer Skin Graft Mesher: medical device reports filed with FDA
3,463 reports name it, 2009–2026. Manufacturer given most often on reports: Zimmer Surgical. Product code FZW.
- 3,463
- device reports naming the brand
- 0% of all MAUDE reports · about 203 a year
- 285
- reports, 12 months to August 2026
- 300 in the 12 months before
- 96%
- classified as malfunction
- 94.9% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 3,463 reports that name the brand "Zimmer Skin Graft Mesher" (expander surgical skin graft), received between June 2009 and August 2026; the manufacturer given most often on reports is Zimmer Surgical. Spellings of one product vary from report to report.
285 reports arrived in the 12 months to August 2026, close to the 300 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 (96%) and injury (4%); across all expander, surgical, skin graft reports (product code FZW) death is recorded in 0% and malfunction in 94.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to cut (31.7%), material twisted/bent (26%) and physical resistance/sticking (12.7%). The patient problems coded most often are no patient involvement, abrasion and tissue damage. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,270 reports carrying product code FZW. 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 |
|---|---|---|---|
| Failure to cut | 1,097 | 31.7% | 43.9% |
| Material twisted/bent | 901 | 26% | 18.2% |
| Physical resistance/sticking | 441 | 12.7% | 10.1% |
| Bent | 255 | 7.4% | 4.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 250 | 7.2% | 6.5% |
| Breakthe device broke | 146 | 4.2% | 2.6% |
| Mechanical jam | 105 | 3% | 2.3% |
| Material deformation | 90 | 2.6% | 2.6% |
| Mechanical problema mechanical problem | 89 | 2.6% | 2.2% |
| Retraction problem | 80 | 2.3% | 1.7% |
| Failure to advance | 71 | 2.1% | 1.5% |
| Fitting problem | 70 | 2% | 1.4% |
| Naturally worn | 62 | 1.8% | 1.9% |
| Difficult to removethe device was hard to remove | 50 | 1.4% | 1.1% |
| Insufficient device problem information | 46 | 1.3% | 1.3% |
| Component missing | 44 | 1.3% | 1.1% |
| Sticking | 37 | 1.1% | 0.6% |
| Patient device interaction problem | 24 | 0.7% | 1.1% |
| Difficult to open or close | 21 | 0.6% | 0.4% |
| Difficult to advance | 20 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 475 | 13.7% |
| Abrasion | 47 | 1.4% |
| Tissue damage | 34 | 1% |
| Laceration(s) | 33 | 1% |
| Skin tears | 28 | 0.8% |
| Graft failure | 11 | 0.3% |
| Complaint, ill-defined | 2 | 0.1% |
| Failure of implant | 1 | 0% |
| Injurya physical injury | 1 | 0% |
| Painpain, site not specified | 1 | 0% |
| Physical entrapment | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zimmer Skin Graft Mesher | Product code FZW | All MAUDE reports |
|---|---|---|---|
| Reports | 3,463 | 5,270 | 26,136,888 |
| Share of that pool | — | 65.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 4% | 5% | 36.2% |
| Classified as malfunction | 96% | 94.9% | 62.3% |
| Filed by the manufacturer | 100% | 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 FZW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 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% |
| Padgett Model S Slimline Electric Dermatome | 247 | 0 | 0% |
| Zimmer Air Dermatome | 2,687 | 372 | 0% |
| Air Dermatome Handpiece | 511 | 0 | 0% |
| Dermatome AN Handpiece | 446 | 117 | 0% |
| Fan Spray Kit | 850 | 173 | 0% |
| Handpiece Electric Dermatome | 1,825 | 174 | 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 Zimmer Skin Graft Mesher reports
How many FDA reports name Zimmer Skin Graft Mesher?
3,463 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 285 in the latest 12 months.
What kinds of events are reported?
malfunction (96%) and injury (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to cut (31.7%), material twisted/bent (26%), physical resistance/sticking (12.7%), bent (7.4%) and device operates differently than expected (7.2%). 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 Zimmer Skin Graft Mesher 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.