Myo/Wire II 040-365Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10841291101734), received between Oct 3, 2018 and Oct 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
RECEIVED NOTIFICATION OF COMPLAINT FROM DEVICE TECHNOLOGIES AUSTRALIA (DISTRIBUTOR) ON (B)(6) 2018 INDICATING PACKAGES OF PART NUMBER 040-365, LOT NUMBER 0624S (STERNOTOMY SUTURE) WERE NOT SEALED ON ONE END. (2 BOXES). THESE TWO BOXES CONTAINING THE UNSEALED PACKAGES WERE REPORTED BY (B)(6). A SUBSEQUENT COMMUNICATION FROM DEVICE TECHNOLOGIES ON (B)(6) 2018 INDICATES THE CUSTOMER ((B)(6)) RETURNED PRODUCT TO DEVICE TECHNOLOGIES THAT WAS NOT ALIGNED TO WHAT WAS INITIALLY REPORTED. DEVICE TECHNOLOGIES IS WORKING WITH METRO NORTH HOSPITAL AND HEALTH SERVICES TO RECONCILE AND WILL REPORT THE RESULT TO A&E MEDICAL. THIS MAY RESULT IN AN ADJUSTMENT TO THE INITIAL COMPLAINT INFORMATION. DUE TO THIS PENDING INFORMATION THIS REPORT WILL BE PRELIMINARY. A FOLLOW-UP (FINAL) REPORT WILL BE EXECUTED ONCE THE INFORMATION IS RECEIVED AND THE RETURNED PRODUCT IS RECEIVED BY A&E MEDICAL AND COMPLAINT IS FULLY INVESTIGATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7930946 ↗
Other Suture, Nonabsorbable devices
- Myo/Wire II 046-367A & E Medical Corporation · Suture, Nonabsorbable4 reports
- 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 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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