INHANCE INTACT 6231-31-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295559856), received between Nov 25, 2025 and Jun 5, 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.

• MalfunctionJun 5, 2026Break

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT 2X INTACT PIN CLAMP DEVICE CLAMPS SHEERED OFF DURING TIGHTENING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25416358 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE TOP SCREW HEAD SHEERED OFF. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25413633 ↗
• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT THE CLAMPS SHEERED OFF DURING TIGHTENING. THERE WAS AN EXTRA DEVICE AVAILABLE SO THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25411362 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT THE PIN CLAMP BROKE WHILE IT WAS BEING TIGHTENED ONTO THE OUTRIGGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957934 ↗
• MalfunctionJan 20, 2026Break; Structural Problem

  IT WAS REPORTED THAT THE CLAMP FAILED TO UNLOCK AND, DURING AN ATTEMPT TO UNLOCK IT, THE HEAD SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24122143 ↗
• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT DURING CLEANING THE WELD BROKE AND DISENGAGED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23913417 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645175 ↗