SUTUREFIX Curved 72205060Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556686300), received between Apr 8, 2019 and Feb 2, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING A LABRUM REPAIR, WHEN THE SUTUREFIX ANCHOR WAS SET AND THE INSERTER WAS BEING REMOVED, THE TIP BROKE OFF. IT WAS STUCK SO TIGHTLY IN THE DRILL GUIDE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; HOWEVER, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232874 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED DURING A HIP JOINT PROCEDURE, TWO (2) SUTUREFIX ULTRA XL WERE PULLED OUT OF THE BONE AFTER THEY WERE DEPLOYED CORRECTLY. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. IT WAS NECESSARY TO DRILL ANOTHER HOLE BECAUSE THIS ANCHOR AND PILOT HOLE WAS SMALL. A CURVED SUTUREFIX DRILL GUIDE AND DRILL BIT OF 1.7MM WAS USED TO PREPARE THE INSERTION SITE. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THERE WAS A 10 MINUTE DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 19058854 ↗
• InjuryMar 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, DUE TO BONE QUALITY, WHEN THE 1.9MM SUTURE FIX ANCHOR WAS PLACED IN THE GLENOID, IT CAME OUT. THUS, IT WAS DECIDED TO PLACE A 2.8MM Q-FIX SUTURE ANCHOR. THE Q-FIX SUTURE ANCHOR WAS PLACED BUT NEVER DEPLOYED. ALL THE DEVICES WERE REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. 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 18980569 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE SUTURE FIX XL ANCHOR INSERTER SHREDDED OFF AS THE ANCHOR WAS BEING INSERTED.. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890237 ↗
• InjuryJun 30, 2021Device Dislodged or Dislocated; Expulsion; Device Dislodged or Dislocated; Expulsion

  IT WAS REPORTED THAT, DURING AN ACETABULAR LABRUM REPAIR SURGERY, A SUTUREFIX XL ANCHOR PULLED OUT OF THE TISSUE. TISSUE DAMAGE HAS OCCURRED AS A RESULT OF THE DEVICE'S DEFICIENCY. THE SEVERITY IS MILD, AND DAMAGE WAS NOT TREATED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. THE PATIENT RECOVERED THE SAME DAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094421 ↗
• InjuryJun 30, 2021Expulsion; Expulsion

  IT WAS REPORTED THAT, DURING AN ACETABULAR LABRUM REPAIR SURGERY, TWO "1.7MM SUTUREFIX XL ANCHORS" PULLED OUT. TISSUE DAMAGE HAS OCCURRED AS A RESULT OF THE DEVICE'S DEFICIENCY. THE SEVERITY IS MILD, AND DAMAGE WAS NOT TREATED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE INTO AN ADDITIONAL BONE HOLE. THE PATIENT RECOVERED THE SAME DAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094383 ↗
• MalfunctionApr 8, 2019Device Slipped

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY THE SUTUREFIX ANCHOR FELL OUT. THERE WAS A LOSS OF TISSUE FIXATION WITH NO ADDITIONAL BONE HOLE REQUIRED. A BACK-UP DEVICE WAS USED TO COMPLETE THE SURGERY. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8493529 ↗