SPEEDSTITCHRecalls & reported problems across all models

We found 5 models of SPEEDSTITCH by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2018 and Oct 23, 2025 — classified as 32 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Material Separation” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SPEEDSTITCH problems

SPEEDSTITCH models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SPEEDSTITCH OM-8850

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  42 reports
• SPEEDSTITCH OM-7000

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  16 reports
• SPEEDSTITCH OM-8087

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports
• SPEEDSTITCH OM-8085

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports
• SPEEDSTITCH OM-8086

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  2 reports

Recent SPEEDSTITCH adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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