SPEEDSTITCH OM-7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00817470001402), received between Mar 11, 2019 and Oct 23, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A SURGERY, IT WAS NOTICED THAT A SPEEDSTITCH DEVICE WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367408 ↗
• MalfunctionOct 13, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE HANDLE OF TWO (2) SPEEDSTITCH DEVICES KEPT BREAKING OFF WHEN IT WAS BEING INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION FOUND THE DEVICE HAVE A BROKEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930705 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE SPEEDSTITCH DEVICE BROKE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING AN UNKNOWN ALTERNATIVE DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16963559 ↗
• MalfunctionApr 11, 2023Break; Break

  IT WAS REPORTED THAT THE SPEEDSTITCH DISPOSABLE NEEDLE BROKE INSIDE THE INSTRUMENT AND THEY WERE UNABLE TO REMOVE IT. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16715711 ↗
• MalfunctionJan 3, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE SHAFT OF THE SPEEDSTITCH CAME OFF. IT IS UNKNOWN WHEN THE EVENT OCCURRED. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142701 ↗
• MalfunctionJan 3, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE SHAFT OF THE SPEEDSTITCH CAME OFF. IT IS UNKNOWN WHEN THE EVENT OCCURRED. A BACK-UP DEVICE WAS AVAILABLE AND NO DELAYS OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142686 ↗
• MalfunctionOct 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP SURGERY, EXTERNAL TO THE PATIENT, THE SHAFT OF THE SPEEDSTITCH PULLED OFF. THE PROCEDURE WAS COMPLETED WITH 3 MINUTES DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720825 ↗
• MalfunctionMay 26, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SPEEDSTITCH DEVICE WAS NOT TAKING THE NEEDLE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890503 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT THE SPEEDSTITCH WAS BROKEN, NO FURTHER INFORMATION. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782639 ↗
• MalfunctionJan 7, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP SURGERY THE SPEEDSTITCH BARROW SEPARATED FROM THE HANDLE. NO PATIENT INJURIES OR DELAY REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11131581 ↗
• MalfunctionDec 8, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY, THE SPEEDSTITCH NEEDLE COULD NOT SEAT ALL THE WAY DOWN AND WOULD NOT RETRACT BACK INSIDE THE INSERTER TUBE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SMITH & NEPHEW DEVICE WAS AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10973065 ↗
• InjuryOct 22, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SURGEON WAS USING THE SPEEDSTITCH GUN FOR CAPSULE CLOSURE IN THE HIP AND UPON REMOVING THE DEVICE FROM THE PATIENT THE SHAFT OF THE SPEEDSTITCH DEVICE WOULD PULL OFF AND REMAIN IN THE CANNULA. THE SURGEON WOULD JUST GRAB THE PIECE STICKING OUT OF CANNULA AND REMOVE BY HAND. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10717541 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SPEEDSTITCH DEVICE WAS MISSING SCREWS AND NOT WORKING PROPERLY. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10189769 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SPEEDSTITCH DEVICE WAS MISSING SCREWS AND NOT WORKING PROPERLY. THIS WAS NOTICED BEFORE THE PROCEDURE; THEREFORE, NO PATIENT WAS INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Patient Involvement

  MAUDE report 10189726 ↗
• MalfunctionJul 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING DURING A PROCEDURE. THERE WAS NO DELAY OR PATIENT INJURIES BUT, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED SINCE NO BACKUP DEVICE WAS AVAILABLE TO COMPLETE IT. ATTEMPTS WERE MADE TO RETRIEVE FURTHER INFORMATION BUT NO RESPONSE HAS BEEN RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814499 ↗
• MalfunctionMar 11, 2019Difficult to Open or Close

  IT WAS REPORTED THAT THERE IS AN ISSUE WITH THE DEVICE, THE LEVER IS NOT CLOSING AND OPENING. NO PATIENT INJURIES OR DELAY WERE REPORTED. PROCEDURE WAS FINISHED WITH A COMPETITOR DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8410136 ↗

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.