Quattro® X Suture Anchor CM-9255Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00887868270277), received between Aug 30, 2022 and Aug 24, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 18, 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.

• MalfunctionAug 24, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50406032 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE ANCHOR FRACTURED DURING IMPACTION AND SCREWING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034807 ↗
• MalfunctionJan 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A SOFT TISSUE FIXATION PROCEDURE, THE ANCHOR TIP FRACTURED WHEN INSERTED INTO THE BONE. ALL PARTS OF THE ANCHOR WERE SUCCESSFULLY REMOVED FROM THE JOINT. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217324 ↗
• MalfunctionNov 19, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725151 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248316 ↗
• MalfunctionMay 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL SURGERY, WHEN THE SURGEON WAS TRYING TO INSERT THE ANCHOR, THE TIP OF ANCHOR BROKE AT THE ONSET OF INSERTION TWICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248314 ↗
• MalfunctionAug 30, 2022Fracture; Fracture

  IT WAS REPORTED DURING SHOULDER SURGERY, AN ANCHOR SCREW TIP HAS BROKEN DURING INSERTION IN SHOULDER. AN ADDITIONAL ANCHOR WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320968 ↗