SPEEDSTITCH OM-8086Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470005899), received between Dec 18, 2019 and Sep 29, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K042031); they may or may not involve this specific model.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE SPEEDSTITCH WAS PASSED THROUGH THE HIP CAPSULE, WHEN IT WAS ATTEMPTED TO TAKE THE DEVICE OUT OF THE JOINT, THE SUTURE CARTRIDGE GOT DISCONNECTED FROM THE PASSER, THE DOCTOR TRIED TO PULL ON THE TUBE THAT HOUSES THE SUTURE AND THE TUBE BECAME SEPARATED FROM THE METAL TIP. SURGEON ENDED UP HAVING TO EXTEND THE INCISION AND ONE OF HIS PORTALS IN ORDER TO RETRIEVED THE METAL TIP THAT WAS GRABBED WITH A HEMOSTAT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED AND THE PATIENT IS DOING WELL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12550720 ↗
• MalfunctionDec 18, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING HIP ARTHROSCOPY, THE SPEEDSTITCH CARTRIDGE BROKE IN THE STITCHER WHILE INSIDE THE PATIENT'S INCISION. NO FRAGMENTS NEEDED TO BE RETRIEVED. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9490505 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042031. One submission often covers many models, so check the product and lot details in each record.

• Z-0611-2012 · Aug 8, 2011 · Terminated
  OPUS SpeedStitch Product Number OM-8086 is a suture cartridge For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.