ULTRABRAIDRecalls & reported problems across all models

We found 11 models of ULTRABRAID by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 256 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2017 and Apr 7, 2026 — classified as 101 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Break” (82 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 ULTRABRAID problems

ULTRABRAID models

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

• ULTRABRAID 72203854

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  107 reports
• ULTRABRAID 72203853

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  68 reports
• ULTRABRAID 72203852

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  38 reports
• ULTRABRAID 72203841

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  13 reports
• ULTRABRAID 7210914

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  9 reports
• ULTRABRAID 72203842

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  8 reports
• ULTRABRAID 7211080

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  4 reports
• ULTRABRAID 7211081

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  4 reports
• ULTRABRAID 72200886

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  3 reports
• Ultrabraid 72203955

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  1 report
• ULTRABRAID 7210915

  SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
  1 report

Recent ULTRABRAID adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA ANCHOR GOT PULLED OUT AFTER DEPLOYMENT DURING TIGHTENING. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800162 ↗
• MalfunctionFeb 10, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR, WHILE TENSIONING THE KNOT OF ONE (1) SUTUREFIX ULTRA, THE ANCHOR CAME OUT FROM THE BONE. ANOTHER BONE HOLE WAS MADE AND PLACED ANOTHER ANCHOR. NO VOID LEFT. THE PATIENT'S STATUS IS GOOD. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24307004 ↗
• MalfunctionFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A BANKART ARTHROSCOPY, ONE (1) SUTUREFIX ANCHOR CAME OUT IMMEDIATELY ALONG WITH THE SLEEVE AFTER DEPLOYMENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. A NEW BONE HOLE WAS DRILLED AT ADJACENT LOCATION. NO VOID LEFT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. THE PATIENT'S STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24245662 ↗
• MalfunctionDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN INSTABILITY PROCEDURE WHILE KNOTTING, THE SUTUREFIX ULTRA AHR S 2 UB STR CB BLU GOT BACKOUT FROM GLENOID BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864014 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778757 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778515 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778151 ↗
• MalfunctionDec 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, IT WAS NOTICED THAT WHILE TENSIONING, THE SUTUREFIX KNOT ANCHOR CAME OUT OF THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. A NEW BONE HOLE WAS DRILLED FOR THE BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 23778049 ↗
• MalfunctionNov 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION+LATERAL RELEASE AND MEDIAL, THE ULTRBRD#2 COBRAID 38 WAS BROKEN, IT WAS IMMEDIATELY REMOVED WITH GRASPER AND TWEEZERS, AND REPLACED WITH AN EQUIVALENT SN BACK UP. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. THE PATIENT'S CONDITION IS STABLE, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659502 ↗
• MalfunctionSep 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, WHEN LOWERING THE THREAD OF THE SUTUREFIX, THE SPECIALIST APPLIED TRACTION OR TENSION TO THE THREAD AND IT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144136 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA HAD A BREAKAGE. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936021 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE FIX ULTRA HAD A BREAKAGE. ALL THE PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935384 ↗
• MalfunctionAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION, THE SUTUREFIX ULTRA GUIDE ANCHOR CAME OUT OF THE BONE HOLE AFTER THE IMPLANT WAS IMPACTED AND UNTIL IT REACHED THE TOP OF THE GUIDE, RIGHT AFTER THE MECHANISM WAS ACTIVATED AND THE STEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE ON AN ADDITIONAL DRILLED BONE HOLE AND LEAVING A VOID IN THE PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO DAMAGE OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22901029 ↗
• MalfunctionAug 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SUTURE OF THE ULTRABRAID DISASSEMBLED FROM THE NEEDLE AFTER 2 STITCHES WERE MADE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877038 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE SUTUREFIX ULTRA ANCHOR BROKE WHILE INSERTING INTO THE DRILLED HOLE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727529 ↗

Other Smith & Nephew, Inc. products

• FAST-FIX18 models · 9,554 reports
• JOURNEY566 models · 6,250 reports · 4 recalls
• GENESIS II462 models · 4,599 reports · 2 recalls
• DYONICS, POWERMAX, ELITE2 models · 4,308 reports
• TRIGEN381 models · 3,599 reports · 5 recalls
• LEGION446 models · 2,039 reports · 4 recalls
• REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
• Coblation62 models · 2,126 reports