Myo/Wire II 046-367Recalls & reported problems
A & E Medical Corporation · SS Suture, 3 per sleeve · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10841291103882), received between Jun 16, 2016 and Aug 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075784 ↗MalfunctionAug 27, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SUTURES ARE BREAKING BEFORE BEING FULLY TWISTED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075783 ↗MalfunctionAug 27, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20075730 ↗MalfunctionJun 16, 2016Unsealed Device Packaging; Unsealed Device Packaging
CUSTOMER RETURNED PRODUCT BECAUSE THEY FOUND THE PRODUCT POUCH (STERILE BARRIER) TO BE UNSEALED. NO PATIENT WAS INVOLVED, OPEN SEAL WAS NOTED DURING PREPARATION FOR PROCEDURE.
Patient problems: No Patient Involvement
MAUDE report 5729204 ↗
Other Suture, Nonabsorbable devices
- Myo/Wire II 040-308A & E Medical Corporation · Suture, Nonabsorbable2 reports
- Myo/Wire II 040-355A & E Medical Corporation · Suture, Nonabsorbable2 reports
- Myo/Wire II 046-093A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 040-397A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-181A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-062A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 040-365A & E Medical Corporation · Suture, Nonabsorbable1 report
- Myo/Wire II 046-267A & E Medical Corporation · Suture, Nonabsorbable1 report
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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