PRONOVA 3776HRecalls & reported problems
Ethicon, LLC · Blue Monofilament Poly(Hexafluoropropylene-VDF), Nonabsorbable Surgical Suture · Class 2 · Implant
All models of PRONOVA (27)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10705031004771), received between Jun 12, 2023 and Jun 12, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Separation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE DOCTOR HAD THE NEEDLE POP OFF OF TWO DIFFERENT SUTURES. HE ALSO ENCOUNTERED THE SUTURE BREAKING WHILE BEING TIED. THIS HAPPENED WITH SUTURES COMING FROM DIFFERENT PACKAGES, BUT FROM THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114093 ↗MalfunctionJun 12, 2023Material Separation; Material Separation
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE DOCTOR HAD THE NEEDLE POP OFF OF TWO DIFFERENT SUTURES. HE ALSO ENCOUNTERED THE SUTURE BREAKING WHILE BEING TIED. THIS HAPPENED WITH SUTURES COMING FROM DIFFERENT PACKAGES, BUT FROM THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114089 ↗MalfunctionJun 12, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE DOCTOR HAD THE NEEDLE POP OFF OF TWO DIFFERENT SUTURES. HE ALSO ENCOUNTERED THE SUTURE BREAKING WHILE BEING TIED. THIS HAPPENED WITH SUTURES COMING FROM DIFFERENT PACKAGES, BUT FROM THE SAME BOX. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17114088 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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