SUTUREFIX Curved 72204689Recalls & reported problems
Smith & Nephew, Inc. · SUTUREFIX CRV AHR S 2 #1 UB STR BL BL-CB · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556686263), received between Apr 3, 2024 and Nov 7, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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, 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
- Material Deformation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking
IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE SUTUREFIX WAS STUCK IN THE DRILL GUIDE AND BROKE WHEN THE SURGEON TOOK OUT THE SUTURE ANCHOR AFTER DEPLOYMENT. IT IS UNCLEAR HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496329 ↗MalfunctionSep 24, 2025Break; Break
IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY PROCEDURE, IT WAS NOTICED THAT A SUTUREFIX SHAFT WAS FRACTURED INSIDE THE SUTURE FIX DRILL GUIDE AFTER INSERTION INTO THE PATIENT. THE BROKEN SHAFT FRAGMENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE SUTURE REMAINED SECURE FIXED IN THE PATIENT. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, USING AN UNKNOWN COMPETITOR DEVICE. NO ADDITIONAL ANESTHESIA WAS REQUIRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 23138042 ↗MalfunctionApr 3, 2024Fracture; Material Deformation; Fracture; Material Deformation
IT WAS REPORTED THAT THE SUTUREFIX INSERTION DEVICE WAS MISSING THE BUTTON AND TRIGGER FROM THE HANDLE, AND THE NOSE TUBE AND SUTURE COVER WERE DAMAGED; THE ENTIRE DISTAL END OF THE DEVICE WAS FRACTURED AWAY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19032665 ↗
Other Fastener, fixation, nondegradable, soft tissue devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 reports
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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