NA 03.117.998Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982073297), received between Jun 28, 2019 and Feb 5, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO BE STERILIZED/ASSEMBLED. THEY WERE CHIPPING AND CRACKING. THEY ARE UNABLE TO BE USED. THIS REPORT IS FOR ONE (1) STRAIGHT/CURVED POINTED REDUCTION FORCEPS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641772 ↗
• MalfunctionJun 28, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ELBOW SURGERY WHEN THE SPIN DOWN NUT GOT STUCK OF THE STRAIGHT/CURVED POINTED REDUCTION FORCEPS ON THREAD. SURGEON HAD TO CUT THE THREAD TO ALLOW THE CLAMP TO BE REMOVED FROM THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A MINIMAL DELAY OF ONE (1) MINUTE. THERE WERE NO FRAGMENTS GENERATED. PATIENT STATUS WAS UNKNOWN. THE INSTRUMENT WAS RECEIVED BROKEN AT THE SPINDLE, IN ADDITION THE SPINDLE IS BENT PREVENTING THE SPEED NUT FROM ADVANCING. THIS REPORT IS FOR A REDUCTION FORCEPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8744013 ↗