INHANCE 6500-36-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295547334), received between Sep 15, 2023 and Aug 26, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50458862 ↗
• MalfunctionJun 1, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT DURING SHOULDER REPAIR SURGERY THE LINER TRIAL WAS SEVERELY CUT FROM IMPACTION AND EXTRACTION. THE SURGEON HAD DIFFICULTY REMOVING THE TRIAL. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349861 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM WAS SHEARED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626403 ↗
• MalfunctionMar 13, 2026Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT LARGE BOWTIE GLENOID REAMER IS DULL. A 36 +0 RETENTIVE LINER TRIAL BECAME DAMAGED WHILE TRYING TO REMOVE. MULTIPLE GOUGES FORMED ON THE UNDERSIDE AND WILL NOT ALLOW IT TO SNAP INTO A SHELL TRIAL. NO PIECES BROKE OFF AND NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED. SURGICAL TIME WAS NOT EXTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590333 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT IT WAS BROKEN AND NEEDED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827713 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004039 ↗
• MalfunctionAug 18, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENT WAS REPORTED FOR UNKNOWN REASON. THE ISSUE DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829820 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED ON 08/01/2025 THAT, WHILE WASHING INSTRUMENTS, THE STERILE PROCESSING TECHNICIAN NOTICED THAT THE 36+0R TAB HAD BROKEN OFF 2 OF THE TRIALS. ALTHOUGH THE PIECES REMAINS INTACT AS ONE PIECE, THEY WERE DEEMED UNUSABLE AND WERE REMOVED FROM THE SET BY PROCESSING TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828837 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT, WHILE WASHING INSTRUMENTS, THE STERILE PROCESSING TECHNICIAN NOTICED THAT THE 36+0R TAB HAD BROKEN OFF 2 OF THE TRIALS. ALTHOUGH THE PIECES REMAINS INTACT AS ONE PIECE, THEY WERE DEEMED UNUSABLE AND WERE REMOVED FROM THE SET BY PROCESSING TECH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828814 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT THE TAB IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396949 ↗
• MalfunctionMay 29, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 36+0 RETENTIVE POLY TRIAL WAS BROKEN. THE TAB WAS BROKEN, SO THE TRIAL WOULD NOT STAY LOCKED INTO THE SHELL TRIAL. NO DELAYS OR ADVERSE EVENTS TOOK PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22107199 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THE FINS THAT SNAP INTO THE SILVER SHELLS SNAPPED OFF. NO SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969605 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC LIP THAT HELPS THE LINER TRIAL SNAP INTO THE TRIAL SHELL BROKE OFF SO IT NO LONGER SNAPS IN.

  Patient problems: Insufficient Information

  MAUDE report 21925777 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT WHILE GOING THROUGH INSTRUMENTS TO TURN THEM OVER FOR CASES, IT WAS NOTICED THAT THESE INSTRUMENTS WERE ALL BROKEN AND NEEDED TO BE REPLACED. THERE WERE NO DELAYS OR ADVERSE EVENTS THAT TOOK PLACE FOR ANY OF THE DOCTOR'S CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881414 ↗
• MalfunctionFeb 19, 2025Break; Break

  IT WAS REPORTED THAT WHEN REMOVING THE TRIAL POLY, THE LOCKING TAB BROKE OFF. ALL PARTS WERE RETRIEVED AND NO SURGICAL DELAYS TOOK PLACE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21414537 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT WHEN REMOVING THE TRIAL POLY, THE LOCKING TAB WAS BROKE OFF. ALL PARTS WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21403513 ↗
• MalfunctionMar 12, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  REVERSE LINER TRIAL 36 +0R BROKEN WILL NOT ATTACTH. RETENTION TAB SNAPPED OFF. THERE WAS NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891751 ↗
• MalfunctionSep 15, 2023Break; Break

  IT WAS REPORTED THAT ON SEPTEMBER 6, 2023 DURING AN INSPECTION OF THE INSTRUMENTS, THE SALES REP NOTICED THE THAT PART OF THE KING TAB ON THE 36 + OR POLY TRIAL SEEMED TO BE BROKEN. THERE WAS NO IMPACT TO THE PATIENT SINCE THIS HAPPENED POST OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760543 ↗