Sequoia® 3301-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 184 adverse event reports that list this exact device (DI 00889024334861), received between Sep 4, 2019 and May 8, 2026 — classified as 4 injuries, 180 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (183 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 184 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Material Deformation

  A CLOSURE TOP WAS RETURNED TO THE MANUFACTURER WITH FRACTURED/STRIPPED THREADS. THIS DAMAGE IS BELIEVED TO HAVE OCCURRED INTRA-OPERATIVELY, HOWEVER THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125350 ↗
• MalfunctionJan 28, 2026Material Deformation

  IT WAS REPORTED THAT BOTH THE INNER HEXAGON AND OUTER THREADS OF THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. NEW CLOSURE TOPS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY TO EXCHANGE THE CLOSURE TOPS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203508 ↗
• MalfunctionJan 28, 2026Material Deformation

  IT WAS REPORTED THAT BOTH THE INNER HEXAGON AND OUTER THREADS OF THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. NEW CLOSURE TOPS WERE USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 10 MINUTE DELAY TO EXCHANGE THE CLOSURE TOPS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203441 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATHFINDER CLOSURE TOP INNER HEXAGON STRIPPED INTRA-OP DURING FINAL TIGHTENING BUT DID NOT RESULT IN ANY PATIENT HARM AND ONLY CAUSED A 10 MINUTE PROCEDURAL DELAY. ANOTHER CLOSURE TOP WAS USED TO FINISH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23869385 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23841439 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840504 ↗
• MalfunctionDec 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE PATHFINDER CLOSURE TOPS WERE DAMAGED WHEN SURGEON FINAL TORQUED THEM: TWO SCREW¿S THREADS WERE BROKEN, AND ONE'S INNER HEXAGON STRIPPED OFF. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY TO PREPARE OTHER CLOSURE TOPS. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840470 ↗
• MalfunctionSep 11, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A SURGERY, THE INNER HEXAGON OF A CLOSURE TOP WAS STRIPPED DURING FINAL TIGHTENING. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED WITH ANOTHER CLOSURE TOP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032849 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020401 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020370 ↗
• MalfunctionMay 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE SEQUOIA CLOSURE TOPS WERE STRIPPED DURING SURGERY. A FOURTH CLOSURE TOP WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT IMPACT; HOWEVER, THERE WAS A 30 MINUTE DELAY. THIS IS REPORT ONE OF THREE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020346 ↗
• MalfunctionJan 29, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING TIGHTENING INTRA-OPERATIVELY, THE OUTER THREADS AND THE DRIVE FEATURE OF A CLOSURE TOP STRIPPED. THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE WHILE THE CLOSURE TOP WAS REMOVED AND REPLACED, BUT NO FURTHER PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266007 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210038 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT.THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210033 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT.THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21210002 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED DURING TORQUE INTRA-OPERATIVELY. THIS RESULTED IN A 30 MINUTE PROCEDURAL DELAY BUT NO PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209978 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED INTRA-OPERATIVELY. THERE WAS A 30 MINUTE DELAY WHILE OTHER CLOSURE TOPS WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT FOUR OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169950 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED INTRA-OPERATIVELY. THERE WAS A 30 MINUTE DELAY WHILE OTHER CLOSURE TOPS WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169820 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED INTRA-OPERATIVELY. THERE WAS A 30 MINUTE DELAY WHILE OTHER CLOSURE TOPS WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169695 ↗
• MalfunctionJan 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT FOUR PATHFINDER CLOSURE TOPS WERE STRIPPED INTRA-OPERATIVELY. THERE WAS A 30 MINUTE DELAY WHILE OTHER CLOSURE TOPS WERE USED TO COMPLETE THE PROCEDURE WITH NO PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21169514 ↗
• MalfunctionJan 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF A SET SCREW, THE TORQUE WRENCH CLICKING SOUND WAS SLUGGISH AND THE SET SCREW WAS DAMAGED. THE SET SCREW WAS REPLACED, HOWEVER THE SECOND AND THIRD SET SCREWS WERE DAMAGED IN THE SAME WAY. THE BONE SCREW WAS ALSO DAMAGED, AND REMOVED AND REPLACED WITH A NEW SCREW, AND THE FINAL TIGHTENING OF THE SET SCREW WAS SUCCESSFUL. THIS CAUSED A 15 MINUTE DELAY TO THE PROCEDURE, HOWEVER THERE WAS NO PATIENT IMPACT. THIS IS REPORT FIVE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21163724 ↗
• MalfunctionDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE STRIPPED CLOSURE TOPS WERE REMOVED AND REPLACED. IT WAS SUSPECTED THAT THE TORQUE WRENCH WAS OVER-TORQUEING AND CONTRIBUTED TO THE DAMAGE. THERE WAS A 30 MINUTE DELAY BUT NO PATIENT IMPACT. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919171 ↗
• MalfunctionDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE STRIPPED CLOSURE TOPS WERE REMOVED AND REPLACED. IT WAS SUSPECTED THAT THE TORQUE WRENCH WAS OVER-TORQUEING AND CONTRIBUTED TO THE DAMAGE. THERE WAS A 30 MINUTE DELAY BUT NO PATIENT IMPACT. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917256 ↗
• MalfunctionDec 12, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE CLOSURE TOPS STRIPPED DURING FINAL TIGHTENING INTRA-OPERATIVELY. THE STRIPPED CLOSURE TOPS WERE REMOVED AND REPLACED. IT WAS SUSPECTED THAT THE TORQUE WRENCH WAS OVER-TORQUEING AND CONTRIBUTED TO THE DAMAGE. THERE WAS A 30 MINUTE DELAY BUT NO PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917062 ↗
• MalfunctionNov 27, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING THE FINAL TIGHTENING OF A SET SCREW, THE TORQUE WRENCH CLICKING SOUND WAS SLUGGISH AND THE SET SCREW WAS DAMAGED. THE SET SCREW WAS REPLACED, HOWEVER THE SECOND AND THIRD SET SCREWS WERE DAMAGED IN THE SAME WAY. THE BONE SCREW WAS ALSO DAMAGED, AND REMOVED AND REPLACED WITH A NEW SCREW, AND THE FINAL TIGHTENING OF THE SET SCREW WAS SUCCESSFUL. THIS CAUSED A 15 MINUTE DELAY TO THE PROCEDURE, HOWEVER THERE WAS NO PATIENT IMPACT. THIS IS REPORT ONE OF FIVE FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792509 ↗