SPEEDSTITCH OM-8850Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00817470005929), received between Apr 9, 2018 and Dec 5, 2023 — classified as 30 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT, DURING A HIP SURGERY, THE SPEEDSTITCH NEEDLE'S UNLOADER WAS ALREADY BROKEN IN TWO PIECES WHEN THE PACKET WAS OPENED AND COULD NOT BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267649 ↗
• MalfunctionMay 22, 2023Failure to Cycle; Material Deformation; Failure to Cycle; Material Deformation

  IT WAS REPORTED THAT TWO (2) SPEEDSTITCH NEEDLE WERE NOT GRASPING THE SUTURE WHEN PASSING IT THROUGH THE HIP CAPSULE. EVENTUALLY, THE NEEDLE TIP BENT AND IT WAS NOT POSSIBLE TO PASS OR CATCH THE SUTURE. SURGERY WAS COMPLETED AFTER A 45-MINUTE DELAY, USING A SLINGSHOT SUTURE PASSER DEVICE FROM STRYKER (COMPETITOR DEVICE). NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976397 ↗
• MalfunctionMay 22, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, A SPEEDSTICH NEEDLE BROKE OFF IN THE CAPSULAR TISSUE, WHEN CLOSING THE CAPSULE WITH THE DEVICE, THE NEEDLE TIP WAS REMOVED FROM TISSUE, WHICH CAUSED A DELAY, HOWEVER UNKNOWN OF HOW MUCH, AS WELL IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16975954 ↗
• InjuryDec 9, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WITH LABRAL REPAIR, THE SPEEDSTITCH NEEDLE BROKE OFF IN THE PATIENT AND NOT ALL THE PIECES WERE REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MIN DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12968557 ↗
• InjuryNov 23, 2021Break; Break

  IT WAS REPORTED THAT DURING A HIP PROCEDURE, INTERNAL TO PATIENT, THE TIP OF THE SPEEDSTITCH NEEDLE BROKE OFF AND WAS NOT ABLE TO BE "FISHED OUT" OF THE HIP CAPSULE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12861836 ↗
• InjuryMay 30, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE SPEEDSTITCH NEEDLE TIP BROKE OFF INSIDE THE PATIENT'S ANATOMY, THE BROKEN PIECES WERE FOUND WITH A SCOPE AND THEN REMOVED. DELAY GREATER THAN 30 MINUTES WAS REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11905797 ↗
• MalfunctionOct 21, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SPEEDSTITCH NEEDLE FAILED TO PASS SUTURE TAPE. THE MALFUNCTION HAPPENED DURING AN UNKNOWN PROCEDURE OUTSIDE THE PATIENT; BUT IT WAS COMPLETED USING A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY. 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 10714899 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY SURGERY THE NEEDLE TIP WAS FAULTY. NO PATIENT INJURIES REPORTED. BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. UNKNOWN IF THERE WAS A DELAY OF THE SURGERY. 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 10189416 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY THE SPEEDSTITCH NEEDLE WAS DAMAGED AT THE END AND WOULD NOT PASS THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF UNDER 30 MIN AND A BACKUP DEVICE WAS AVAILABLE. NO INJURY TO THE PATIENT 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 10189336 ↗
• MalfunctionJun 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY THE SPEEDSTITCH NEEDLE WAS DAMAGED AT THE END AND WOULD NOT PASS THE SUTURE. THE PROCEDURE WAS COMPLETED WITH A DELAY OF UNDER 30 MIN AND A BACKUP DEVICE WAS AVAILABLE. NO INJURY TO THE PATIENT 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 10189282 ↗
• MalfunctionJun 23, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A HIP ARTHROSCOPY, THE SPEEDSTITCH NEEDLE WAS BENDING OVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES 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 Known Impact Or Consequence To Patient

  MAUDE report 10187146 ↗
• InjuryJun 8, 2020Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING A HIP SCOPE, A SPEEDSTITCH NEEDLE BROKE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A COMPETITOR DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10131073 ↗
• InjuryJun 8, 2020Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING A HIP SCOPE, A SPEEDSTITCH NEEDLE BROKE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACKUP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10130935 ↗
• InjuryJun 8, 2020Break; Break

  IT WAS REPORTED THAT WHEN THE SURGEON WAS PERFORMING A HIP SCOPE, A SPEEDSTITCH NEEDLE BROKE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACKUP DEVICE. NO 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 Known Impact Or Consequence To Patient

  MAUDE report 10130880 ↗
• InjuryMay 30, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE, WHEN DEPLOYING THE DEVICE TO PASS THE TAPE OR SUTURE THE NEEDLE WOULD JAM OR BREAK THE TIP OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103835 ↗
• InjuryMay 30, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE, WHEN DEPLOYING THE DEVICE TO PASS THE TAPE OR SUTURE THE NEEDLE WOULD JAM OR BREAK THE TIP OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103830 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE, WHEN DEPLOYING THE DEVICE TO PASS THE TAPE OR SUTURE THE NEEDLE WOULD JAM OR BREAK THE TIP OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103818 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE, WHEN DEPLOYING THE DEVICE TO PASS THE TAPE OR SUTURE THE NEEDLE WOULD JAM OR BREAK THE TIP OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. 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: Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103816 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE IN THE HIP, THE NEEDLE WOULD FAIL TO PASS THE STITCH OR MINI TAPE AND WOULD SOMETIMES BREAK OFF OR BEND. THE BROKEN PIECE COULD NOT BE RETRIEVED SINCE IT WAS BURIED IN CAPSULE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103814 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE IN THE HIP, THE NEEDLE WOULD FAIL TO PASS THE STITCH OR MINI TAPE AND WOULD SOMETIMES BREAK OFF OR BEND. THE BROKEN PIECE COULD NOT BE RETRIEVED SINCE IT WAS BURIED IN CAPSULE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103813 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE USING THE SPEEDSTITCH TO CLOSE THE CAPSULE IN THE HIP, THE NEEDLE WOULD FAIL TO PASS THE STITCH OR MINI TAPE AND WOULD SOMETIMES BREAK OFF OR BEND. THE BROKEN PIECE COULD NOT BE RETRIEVED SINCE IT WAS BURIED IN CAPSULE TISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING THE SAME DEVICE. NO 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: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10103808 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP CAPSULE CLOSURE WHEN USING A SPEEDSTITCHES, WHEN DEPLOYING THE NEEDLES TO PASS THE SUTURES OR TAPE, THE NEEDLES TIP WOULD BEND AND IN SOME CASES IT BROKE OFF AT THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, NO SIGNIFICANT DELAY REPORTED. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10103765 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP CAPSULE CLOSURE WHEN USING A SPEEDSTITCHES, WHEN DEPLOYING THE NEEDLES TO PASS THE SUTURES OR TAPE, THE NEEDLES TIP WOULD BEND AND IN SOME CASES IT BROKE OFF AT THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, NO SIGNIFICANT DELAY REPORTED. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10103763 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP CAPSULE CLOSURE WHEN USING A SPEEDSTITCHES, WHEN DEPLOYING THE NEEDLES TO PASS THE SUTURES OR TAPE, THE NEEDLES TIP WOULD BEND AND IN SOME CASES IT BROKE OFF AT THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, NO SIGNIFICANT DELAY REPORTED. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10103762 ↗
• InjuryMay 30, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A HIP CAPSULE CLOSURE WHEN USING A SPEEDSTITCHES, WHEN DEPLOYING THE NEEDLES TO PASS THE SUTURES OR TAPE, THE NEEDLES TIP WOULD BEND AND IN SOME CASES IT BROKE OFF AT THE TIP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, NO SIGNIFICANT DELAY REPORTED. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10103760 ↗

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.