INHANCE 6200-51-205Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295539261), received between Jan 10, 2023 and May 14, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175063 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT THE 5 REVERSE HUMERAL TRIALS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24087278 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT 5 BROKEN REVERSE HUMERAL TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066612 ↗
• MalfunctionDec 2, 2025Crack; Crack

  IT WAS REPORTED THAT DURING ROUTINE CLEANING AND MAINTENANCE IT WAS DISCOVERED THAT TWO INSTRUMENTS HAD BEEN DAMAGED AND NEEDED TO BE REPLACED. BOW TIE REAMER APPEARED DAMAGED. HEAD CRACKED. NO MISSING PIECES. NO ADVERSE EVENTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693491 ↗
• MalfunctionNov 10, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE HUMERAL HEAD TRIAL CLIP DEVICE WAS BROKEN. IT WAS FURTHER REPORTED THAT THE PLASTIC PORTION CRACKED AND BROKE IN TWO PIECES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511228 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT PLASTIC PEGS ON BACKSIDE OF TRIAL SHELLS BROKE OFF DURING SURGERY. IT BROKE ON BACK TABLE DISASSEMBLING TRIALS, NOT IN A PATIENT. ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840935 ↗
• MalfunctionMay 30, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC FOR OFFSET WAS BROKEN AND NEEDS TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117350 ↗
• MalfunctionJan 22, 2024Break; Break

  IT WAS REPORTED THAT RETAINING TABS ON INSIDE OF TRIAL HEAD SHEERED OFF DURING ADAPTER REMOVAL. SURGICAL DELAY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553514 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT THE HUMERAL HEAD TRIAL WAS BROKEN AND THE ADAPTOR WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031556 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT THE TABS ARE BROKEN ON THE HEADS. ASSUME THEY WERE BROKEN IN DECONTAMINATION WHILE REMOVING THE TRIAL ADAPTER. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274812 ↗
• MalfunctionJan 31, 2023Break; Break

  IT WAS REPORTED THAT THE TABS ARE BROKEN ON THE HEADS. ASSUME THEY WERE BROKEN IN DECONTAMINATION WHILE REMOVING THE TRIAL ADAPTER. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274777 ↗
• MalfunctionJan 10, 2023Break; Break

  IT WAS REPORTED THAT HEAD TRIALS BROKE WHILE DISENGAGING/ENGAGING OFFSET ADAPTER. THERE WAS 10 MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 16132428 ↗