Devices › Suture, nonabsorbable, synthetic, polyethylene
Device brand name · Suture nonabsorbable synthetic polyethylene
Ethibond Extra & Excel Polyester Suture Unknown: medical device reports filed with FDA
719 reports name it, 2018–2026. Manufacturer given most often on reports: Ethicon. Product code GAT.
- 719
- device reports naming the brand
- 0% of all MAUDE reports · about 85 a year
- 32
- reports, 12 months to August 2026
- 92 in the 12 months before
- 1.1%
- classified as malfunction
- 72.7% across the product code
- 1.3%
- classified as death, as reported
- 9 reports · not verified by FDA
FDA's MAUDE database holds 719 reports that name the brand "Ethibond Extra & Excel Polyester Suture Unknown" (suture nonabsorbable synthetic polyethylene), received between January 2018 and March 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
32 reports arrived in the 12 months to August 2026, down 65% from 92 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 injury (97.6%), death (1.3%) and malfunction (1.1%); across all suture, nonabsorbable, synthetic, polyethylene reports (product code GAT) death is recorded in 0.2% and malfunction in 72.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient-device incompatibility (2.4%), break (1.8%) and insufficient device problem information (1.1%). The patient problems coded most often are not applicable, pain and hernia. 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 20,369 reports carrying product code GAT. 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 |
|---|---|---|---|
| Patient-device incompatibilitythe device did not suit the patient | 17 | 2.4% | 0.2% |
| Breakthe device broke | 13 | 1.8% | 15.8% |
| Insufficient device problem information | 8 | 1.1% | 1% |
| Loose or intermittent connection | 6 | 0.8% | 0.5% |
| Material separation | 6 | 0.8% | 5% |
| Migrationthe device moved from where it was placed | 6 | 0.8% | 0.3% |
| Material erosion | 5 | 0.7% | 0% |
| Migration or expulsion of device | 4 | 0.6% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 0.4% | 1.7% |
| Material protrusion/extrusion | 3 | 0.4% | 0.1% |
| Fracturea broken bone | 2 | 0.3% | 0.3% |
| Leak/splashthe device leaked | 2 | 0.3% | 0% |
| Calcified | 1 | 0.1% | 0% |
| Compatibility problem | 1 | 0.1% | 0% |
| Contamination | 1 | 0.1% | 0% |
| Crackthe device cracked | 1 | 0.1% | 0.2% |
| Material frayed | 1 | 0.1% | 0.5% |
| Positioning failure | 1 | 0.1% | 3.8% |
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 |
|---|---|---|
| Not applicable | 171 | 23.8% |
| Painpain, site not specified | 111 | 15.4% |
| Hernia | 59 | 8.2% |
| Granuloma | 48 | 6.7% |
| Hemorrhage/blood loss/bleeding | 48 | 6.7% |
| Hematomaa collection of blood under the skin or in tissue | 45 | 6.3% |
| Post operative wound infection | 37 | 5.1% |
| Blood loss | 36 | 5% |
| Wound dehiscencea wound reopened | 36 | 5% |
| Erosion | 34 | 4.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 30 | 4.2% |
| Incontinence | 30 | 4.2% |
| Seromaa collection of fluid under the skin | 29 | 4% |
| Obstruction/occlusion | 25 | 3.5% |
| Fever | 22 | 3.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ethibond Extra & Excel Polyester Suture Unknown | Product code GAT | All MAUDE reports |
|---|---|---|---|
| Reports | 719 | 20,369 | 26,136,888 |
| Share of that pool | — | 3.5% | 0% |
| Classified as death, per 1,000 reports | 13 | 2 | 9 |
| Classified as injury | 97.6% | 26.9% | 36.2% |
| Classified as malfunction | 1.1% | 72.7% | 62.3% |
| Filed by the manufacturer | 100% | 98.9% | 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 GAT
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Fast-Fix 360 Curved Ndl Delivery Sys | 8,299 | 1,755 | 0% |
| Ultra Fast-Fix Assembly - Curved | 1,093 | 64 | 0% |
| Fast-Fix 360 Reversed Curve Ndl Deliv | 691 | 109 | 0% |
| Ff Flex Crvd Instr | 561 | 325 | 0% |
| Fast-Fix 360 Curved Ndl Dlvry Sys Ei | 448 | 0 | 0% |
| Fast Fix Flx Crvd Insrtr Bndr Cann Set | 432 | 167 | 0% |
| V-Loc | 366 | 72 | 0% |
| Ultra Fast-Fix Ab Assembly - Curved | 305 | 9 | 0% |
| Ti-Cron | 237 | 28 | 0.4% |
| Mersilene Polyester Fiber Suture Unknown Product | 197 | 4 | 1.5% |
| Eb Exc Grn 36in 4-0 D/A Rb-1 | 186 | 14 | 0% |
| Meniscal Cinch | 178 | 18 | 0% |
| Fast-Fix 360 Straight Ndl Delivery Sy | 159 | 10 | 0% |
| Fst Fix Flx Rev Crvd Insrtr Bndr Cann St | 152 | 50 | 0% |
| ETHIBOND Extra & Excel Polyester Suture | 317 | 34 | 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 Ethibond Extra & Excel Polyester Suture Unknown reports
How many FDA reports name Ethibond Extra & Excel Polyester Suture Unknown?
719 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 32 in the latest 12 months.
What kinds of events are reported?
injury (97.6%), death (1.3%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient-device incompatibility (2.4%), break (1.8%), insufficient device problem information (1.1%), loose or intermittent connection (0.8%) and material separation (0.8%). 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 Ethibond Extra & Excel Polyester Suture Unknown 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.