Ti Screw ES 902572Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304404328), received between Oct 22, 2020 and Apr 14, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO INSERT THE IMPLANT INTO THE PATIENT'S ROTATOR CUFF, THE IMPLANT FRACTURED. ALL PIECES AND FRAGMENTS OF THE IMPLANT WERE REMOVED FROM THE PATIENT. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21833901 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING ARTHROSCOPIC SURGERY IN THE SHOULDER JOINT, THE ANCHOR BROKE WHILE SCREWING INTO THE HUMERUS. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454116 ↗
• InjuryMar 10, 2022Fracture; Fracture

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

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721318 ↗
• MalfunctionOct 22, 2020Fracture; Failure to Advance; Material Twisted/Bent; Fracture; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED APPROXIMATELY FOUR (4) WEEKS AGO DURING A ROTATOR CUFF REPAIR SURGERY, THE DEVICE FAILED TO ADVANCE THROUGH THE CORTEX. THE SURGEON TRIED TWO (2) DEVICES, ONE (1) BROKE AND ONE (1) BENT. THERE WAS A THIRTY (30) MINUTE DELAY WHILE THE SURGEON LOCATED AND REMOVED THE BROKEN PART FROM THE PATIENT. SURGEON USED A THIRD DEVICE TO COMPLETE THE SURGERY WITH NO ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10717396 ↗
• MalfunctionOct 22, 2020Fracture; Failure to Advance; Material Twisted/Bent; Fracture; Failure to Advance; Material Twisted/Bent

  IT WAS REPORTED APPROXIMATELY FOUR (4) WEEKS AGO DURING A ROTATOR CUFF REPAIR SURGERY, THE DEVICE FAILED TO ADVANCE THROUGH THE CORTEX. THE SURGEON TRIED TWO (2) DEVICES, ONE (1) BROKE AND ONE (1) BENT. THERE WAS A THIRTY (30) MINUTE DELAY WHILE THE SURGEON LOCATED AND REMOVED THE BROKEN PART FROM THE PATIENT. SURGEON USED A THIRD DEVICE TO COMPLETE THE SURGERY WITH NO ISSUES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Consequences Or Impact To Patient

  MAUDE report 10717394 ↗