PDS PDP398GRecalls & reported problems
Ethicon, LLC · Antibacterial Violet Monofilament (Polydioxanone), Absorbable Surgical Suture · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031218727), received between Jun 22, 2020 and Jan 22, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2024Break; Break
IT WAS REPORTED THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. A BROKEN NEEDLE OCCURRED DURING SURGERY AND WAS LOST INSIDE A PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18560359 ↗MalfunctionJun 22, 2020Break; Break
IT WAS REPORTED BY VET THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE KEPT BREAKING DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10182390 ↗MalfunctionJun 22, 2020Break; Break
IT WAS REPORTED BY VET THAT AN ANIMAL UNDERWENT AN ANIMAL SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE KEPT BREAKING DURING SURGERY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10182375 ↗
Other SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE devices
- STRATAFIX SXPP1A405Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE617 reports
- STRATAFIX SXPP1A400Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE485 reports
- STRATAFIX SXPP1A401Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE446 reports
- STRATAFIX SXPP1A301Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE443 reports
- STRATAFIX SXPP2B405Ethicon, LLC · Suture, surgical, absorbable, polydioxanone406 reports
- STRATAFIX SXPP1A406Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE339 reports
- STRATAFIX SXPP1A404Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death319 reports
- STRATAFIX SXPP1B420Ethicon, LLC · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 death229 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.