Devices › Suture, surgical, absorbable, polydioxanone
Device brand name · Barbed material/needles
Stratafix Knotless Tissue Control Device: medical device reports filed with FDA
225 reports name it, 2013–2016. Manufacturer given most often on reports: Surgical Specialties Puerto Rico. Product code NEW.
- 225
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 27.6%
- classified as malfunction
- 76.8% across the product code
- 0.4%
- classified as death, as reported
- 1 reports · not verified by FDA
225 medical device reports received by FDA name the brand "Stratafix Knotless Tissue Control Device" (barbed material/needles); the manufacturer given most often on reports is Surgical Specialties Puerto Rico; received from May 2013 to February 2016. 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 other (62.7%), malfunction (27.6%) and death (0.4%); 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 (28.4%), insufficient device problem information (25.8%) and device operates differently than expected (10.7%). The patient problems coded most often are wound dehiscence, impaired healing and erythema. 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 Stratafix Knotless Tissue Control Device was received in the five years to August 2026; the latest was received in February 2016.
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 | 64 | 28.4% | 50.7% |
| Insufficient device problem information | 58 | 25.8% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 24 | 10.7% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 19 | 8.4% | 0.2% |
| Extrusion | 13 | 5.8% | 0.1% |
| Device or device fragments location unknown | 6 | 2.7% | 0% |
| Detachment of device component | 5 | 2.2% | 1.2% |
| Material erosion | 5 | 2.2% | 0% |
| Material discolored | 4 | 1.8% | 0.1% |
| Device slipped | 3 | 1.3% | 0% |
| Material fragmentation | 3 | 1.3% | 0.1% |
| Component missing | 2 | 0.9% | 0.1% |
| Difficult to removethe device was hard to remove | 2 | 0.9% | 0% |
| Material deformation | 2 | 0.9% | 0% |
| Structural problem | 2 | 0.9% | 0% |
| Torn material | 2 | 0.9% | 0% |
| Unraveled material | 2 | 0.9% | 0% |
| Component falling | 1 | 0.4% | 0% |
| Defective component | 1 | 0.4% | 0.6% |
| Degraded | 1 | 0.4% | 0% |
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 | 72 | 32% |
| Impaired healingslow healing | 27 | 12% |
| Erythemaskin redness | 14 | 6.2% |
| Skin irritationirritated skin | 14 | 6.2% |
| Purulent discharge | 10 | 4.4% |
| Scarring | 10 | 4.4% |
| Skin inflammation | 10 | 4.4% |
| Tissue breakdown | 10 | 4.4% |
| Hemorrhage/blood loss/bleeding | 8 | 3.6% |
| Device embedded in tissue or plaque | 6 | 2.7% |
| Rashskin rash | 5 | 2.2% |
| Failure to anastomose | 4 | 1.8% |
| Fluid discharge | 4 | 1.8% |
| Bacterial infectiona bacterial infection | 3 | 1.3% |
| Hematomaa collection of blood under the skin or in tissue | 3 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Stratafix Knotless Tissue Control Device | Product code NEW | All MAUDE reports |
|---|---|---|---|
| Reports | 225 | 16,088 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 4 | 3 | 9 |
| Classified as injury | 0.4% | 21.2% | 36.2% |
| Classified as malfunction | 27.6% | 76.8% | 62.3% |
| Filed by the manufacturer | 99.1% | 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 |
|---|---|---|---|
| Stratafix | 925 | 647 | 0.1% |
| 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% |
| 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 Knotless Tissue Control Device reports
How many FDA reports name Stratafix Knotless Tissue Control Device?
225 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?
other (62.7%), malfunction (27.6%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (28.4%), insufficient device problem information (25.8%), device operates differently than expected (10.7%), patient-device incompatibility (8.4%) and extrusion (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Stratafix Knotless Tissue Control Device 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.