NA 398.226Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982201317), received between May 18, 2021 and Mar 19, 2026 — classified as 4 malfunctions.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT THE SCREW FROM THE FORCEP CAME OUT AND CANNOT BE ADDED BACK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642234 ↗
• MalfunctionNov 1, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS CONFIRMED THAT THE SCREW PART OF THE REDUCTION FORCEPS WAS HARD. BEFORE THE SURGERY, THE NURSE WAS CHECKING THE FUNCTIONALITY OF THE REDUCTION FORCEPS AND FOUND THAT THE SCREW PART WAS HARD, AND WHEN THE SCREW PART WAS TURNED, THE METAL IN THE CONTACT PART HAS BEEN SHAVED LIKE A WIRE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) PERIARTICULAR REDUCTION FORCEPS-MEDIUM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727849 ↗
• MalfunctionMay 19, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MEDIUM REDUCTION FORCEPS WHERE THERE WAS NO ADVERSE EVENT. IT CAME THROUGH THE WASH AND THE END STOPPER THAT HOLD THE SPIN-DOWN KNOT CAME OFF AND THE KNOT IS COMPLETELY OFF AND LOST IN THE WASH SOMEWHERE. THIS IS THE END CAP THAT PREVENTS THE SPIN-DOWN KNOT FROM COMING OFF OF THE THREADED ROD IF IT¿S NOT REPAIRABLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11852772 ↗
• MalfunctionMay 18, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT BY THE STERILE PROCESSING DEPARTMENT THAT THE SPIN WHEEL ON THE PERIARTICULAR CLAMP WAS NO LONGER SPINNING SMOOTHLY. NO PATIENT INVOLVEMENT. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE PIVOT SCREW WAS RECEIVED DISASSEMBLED FROM THE DEVICE AND THE STAKE TO HOLD THE PIVOT SCREW IN PLACE WAS BROKEN. THIS REPORT IS FOR ONE (1) PERIARTICULAR REDUCTION FORCEPS-MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842080 ↗