NA 399.79Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982203076), received between Jun 26, 2019 and Jun 26, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2019Break; Break

  07/18/2019: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2019, THE REDUCTION FORCEPS WAS USED TO REDUCE A DISTAL RADIUS FRACTURE WERE THE CLAMP ON A SPEND DOWN WOULD NOT COME UNDONE. THE CLAMP HAD TO BE CLIP THE PART WITH A ROD CUTTER BUT THE REDUCTION FORCEPS WAS BROKEN. DR CLARK THEN DECIDED TO REMOVE CLAMP, IN WHICH THE CLAMP WOULD NOT RELEASE OR LOOSEN. TO COMPLETE THE PROCEDURE, DR CLARK FIRST GRABBED A SET OF PLIERS TO TRY AND LOOSEN THE NUT ON THE CLAMP, BUT IT WOULD NOT LOOSEN. NEXT, HE REQUESTED A LARGE ROD CUTTER TO CUT THE CLAMP LOOSE. HE WAS ABLE TO DO THIS SUCCESSFULLY. WHEN CLAMP WAS CUT WITH ROD CUTTER, ONLY ONE FRAGMENT WAS PRODUCED FROM BROKEN DEVICE, AND IT WAS COLLECTED EASILY AND IMMEDIATELY AFTER CLAMP WAS REMOVED. THE BROKEN CLAMP WAS COLLECTED AND CLEANED AFTER THE CASE. THERE WAS A SURGICAL DELAY OF 5 MINUTES. PATIENT OUTCOME WAS SUCCESSFUL. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES (1) DEVICE.

  Patient problems: No Code Available

  MAUDE report 8737414 ↗