NA 03.111.750Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982072566), received between Feb 1, 2021 and Feb 26, 2026 — classified as 7 malfunctions.

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

• MalfunctionFeb 26, 2026Break; Material Deformation

  IT WAS REPORTED THE CLAMPS BECAME WARPED IN SPD. FORCEPS WERE USED IN THE CASE AND BROKE IN SPD. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455260 ↗
• MalfunctionFeb 26, 2026Break; Material Deformation

  IT WAS REPORTED THE CLAMPS BECAME WARPED IN SPD. FORCEPS WERE USED IN THE CASE AND BROKE IN SPD. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455143 ↗
• MalfunctionJan 24, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECIEVED AND STATED THAT THE EVENT OCCURRED DURING POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229538 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED THAT, THE "J" PIECE OF THE CLAMP GOT SNAPPED OFF AND IS NO LONGER ABLE TO BE USED AND THE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS BROKE DURING INTRAOPERATIVE USE. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19035342 ↗
• MalfunctionDec 26, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY WITH THE VA TCP FOR A DISTAL RADIUS FRACTURE. WHEN THE SOFT TISSUE ATTACHMENT WAS ATTACHED TO THE REDUCTION FORCEPS BALL TIPS, THE MOUNTING PART SHATTERED OUTSIDE THE PATIENT¿S BODY. ALTHOUGH THE SOFT TISSUE ATTACHMENT COULD NOT BE ATTACHED, THE DEVICE WAS USED AS-IS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18393754 ↗
• MalfunctionApr 21, 2021Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A CASE A FORCEPS TOOL WAS NOT USED DUE TO INSTRUMENT BEING BROKEN. A SECOND SET ON SITE WAS OPENED TO DO THE CASE IN INSTRUMENTATION SET-UP BEFORE THE PATIENT WAS FULLY ANAESTHETIZED. THIS REPORT IS FOR A SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702248 ↗
• MalfunctionFeb 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, THE TIP OF THE REDUCTION HEAD-ANGLED BROKE OFF. THE SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS AND SOFT TISSUE ATTACHMENT J-SHAPE F/REDUCTION FORCEPS BALL AND PLASTIC PIECE BROKE. THE REDUCTION TOOL/CURVED WITH QUICK COUPLING WOULDN¿T ATTACH TO T HANDLE QUICK COUPLING (QC); IT SEEMED TO BE CROSS THREADED. TWO (2) 1.8MM COAXIAL DRILL GUIDES CROSS THREADED. TWO (2) RETRACTOR FOR SCIATIC NERVE WERE BENT. AND THE TIP OF THE REAMING ROD PUSH ROD BROKE OFF. ALL EQUIPMENT WAS USED DURING SURGERY AND HAD MALFUNCTIONED. SURGERY WAS DELAYED FIVE TO 10 (5-10) MINUTES. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A SOFT TISSUE BONE REDUCTION FORCEPS WITH BALL TIPS. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262316 ↗