Devices › Suture, surgical, absorbable, polydioxanone
Device brand name · Suture surgical absorbable polydioxanone
Stratafix: medical device reports filed with FDA
925 reports name it, 2017–2026. Manufacturer given most often on reports: Ethicon. Product code NEW.
- 925
- device reports naming the brand
- 0% of all MAUDE reports · about 104 a year
- 647
- reports, 12 months to August 2026
- 38 in the 12 months before
- 74.8%
- classified as malfunction
- 76.8% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 925 reports that name the brand "Stratafix" (suture surgical absorbable polydioxanone), received between August 2017 and August 2026; the manufacturer given most often on reports is Ethicon. Spellings of one product vary from report to report.
647 reports arrived in the 12 months to August 2026, up 1603% from 38 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 (74.8%), injury (25.1%) and death (0.1%); across all suture, surgical, absorbable, polydioxanone reports (product code NEW) death is recorded in 0.3% and malfunction in 76.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (42.8%), material separation (19.8%) and positioning failure (5.7%). The patient problems coded most often are wound dehiscence, foreign body in patient and impaired healing. 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 16,088 reports carrying product code NEW. 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 |
|---|---|---|---|
| Breakthe device broke | 396 | 42.8% | 50.7% |
| Material separation | 183 | 19.8% | 19.8% |
| Positioning failure | 53 | 5.7% | 2.9% |
| Detachment of device or device componentpart of the device came off | 52 | 5.6% | 1.3% |
| Failure to degrade | 15 | 1.6% | 0.1% |
| Material protrusion/extrusion | 14 | 1.5% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 13 | 1.4% | 0.2% |
| Insufficient device problem information | 11 | 1.2% | 1% |
| Material frayed | 10 | 1.1% | 0.8% |
| Failure to adhere or bond | 9 | 1% | 0.7% |
| Device appears to trigger rejection | 8 | 0.9% | 0.1% |
| Material integrity problema problem with the device material | 8 | 0.9% | 2.4% |
| Material twisted/bent | 8 | 0.9% | 0.3% |
| Detachment of device component | 7 | 0.8% | 1.2% |
| Delivered as unsterile product | 5 | 0.5% | 0.4% |
| Device contaminated during manufacture or shipping | 5 | 0.5% | 0.3% |
| Device fell | 5 | 0.5% | 0% |
| Difficult or delayed positioning | 5 | 0.5% | 0% |
| Component misassembled | 4 | 0.4% | 0.3% |
| Product quality problem | 4 | 0.4% | 0.1% |
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 |
|---|---|---|
| Wound dehiscencea wound reopened | 86 | 9.3% |
| Foreign body in patientpart of a device left in the patient | 61 | 6.6% |
| Impaired healingslow healing | 31 | 3.4% |
| Not applicable | 19 | 2.1% |
| Post operative wound infection | 16 | 1.7% |
| Pocket erosion | 12 | 1.3% |
| Fluid discharge | 10 | 1.1% |
| Skin irritationirritated skin | 10 | 1.1% |
| Device embedded in tissue or plaque | 7 | 0.8% |
| Abscessa collection of pus | 6 | 0.6% |
| Granuloma | 6 | 0.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 5 | 0.5% |
| Foreign body reaction | 5 | 0.5% |
| Painpain, site not specified | 5 | 0.5% |
| Ulcer | 5 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Stratafix | Product code NEW | All MAUDE reports |
|---|---|---|---|
| Reports | 925 | 16,088 | 26,136,888 |
| Share of that pool | — | 5.7% | 0% |
| Classified as death, per 1,000 reports | 1 | 3 | 9 |
| Classified as injury | 25.1% | 21.2% | 36.2% |
| Classified as malfunction | 74.8% | 76.8% | 62.3% |
| Filed by the manufacturer | 97.1% | 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 NEW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct | 427 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctb-1 | 343 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ctx | 308 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct-1 | 302 | 0 | 0% |
| Stratafix Symmetric Pds Plus Knotless Tissue Control Device | 270 | 0 | 0% |
| Sfxspi Pds+ Bi Vio 14in2 1 Da Ctx | 260 | 0 | 0% |
| Sfx Sym Pds+ Uni Vio 18in 1 S/A Ct-1 | 220 | 0 | 0.5% |
| Sfx Sym Pds+ Uni Vio 18in 0 S/A Ct | 207 | 0 | 0% |
| Pds | 211 | 199 | 0% |
| Stratafix Unknown | 198 | 15 | 0.5% |
| Stratafix Knotless Tissue Control Device | 225 | 0 | 0.4% |
| Sfx Spi Pds+ Bi Vio 14in2 Usp1 D/A Ctx | 183 | 101 | 0% |
| Pds Plus Antibacterial Polydioxanone Suture | 156 | 0 | 0% |
| Suture Unknown | 469 | 39 | 0.6% |
| Absorbable Surgical Suture Usp | 361 | 27 | 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 Stratafix reports
How many FDA reports name Stratafix?
925 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 647 in the latest 12 months.
What kinds of events are reported?
malfunction (74.8%), injury (25.1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (42.8%), material separation (19.8%), positioning failure (5.7%), detachment of device or device component (5.6%) and failure to degrade (1.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.1%) and voluntary reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Stratafix 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.