INHANCE 6500-40-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295547389), received between Feb 7, 2023 and Sep 10, 2026 — classified as 11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50721727 ↗
• MalfunctionJun 18, 2026Crack

  IT WAS REPORTED THE TABS BROKE OFF OF TWO POLY TRIALS IN THE INHANCE TRAY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25546533 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE THE PLASTIC LOCKING CLIP ON POLY TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844026 ↗
• MalfunctionMar 12, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586579 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED THAT THE PLASTIC LOCKING TAB ON SIDE OF REVERSE LINER 40+0 TRIAL BROKE DURING TRIALING. SINGLE BROKEN TAB PIECE WAS RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 21172610 ↗
• MalfunctionJan 15, 2025Break; Material Deformation; Scratched Material; Break; Material Deformation; Scratched Material

  IT WAS REPORTED THAT RETENTION TABS ON REVERSE LINER TRIALS ARE COMPROMISED AND NO LONGER FUNCTIONAL DUE TO GOUGING, SHEARED OFF, OR BENT OUT OF PROPER SHAPE. EVENT OCCURRED DURING POST-OP RESET AND INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21159777 ↗
• MalfunctionJun 26, 2024Crack; Crack

  FOUND DURING ROUTINE INSPECTION OF INSTRUMENT TRAYS IN FIELD SALES OFFICE. INHANCE TRIAL 40+0, HAS CRACKS IN NEAR THE BOTTOM OF IT. STILL IN 1 PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19617912 ↗
• MalfunctionMay 1, 2024Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE POLY TRIAL TAB WAS CRACKED AND WOULD NOT CLIP INTO REVERSE SHELL TRIAL.

  Patient problems: Insufficient Information

  MAUDE report 19220195 ↗
• MalfunctionJul 31, 2023Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  PLEASE VERIFY IF THE INSTRUMENT WAS USED DURING SURGERY. IF YES, WAS THERE A SURGICAL DELAY? YES, INSTRUMENTS WERE USED. WHAT WAS THE DURATION OF THE DELAY? NO DELAY. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17423835 ↗
• MalfunctionMar 16, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE 40 +0 POLY TRIAL WOULD NOT STAY ENGAGED IN THE HUMERAL SHELL TRIAL WHEN TRIAL REDUCING THE SHOULDER. SAME THING HAPPENED WITH THE 40 +0 RETENTIVE TRIAL AS WELL. WHEN THE SURGEON LOOKED AT THE POLY TRIALS, HE MENTIONED THE TABS THAT LOCK INTO THE HUMERAL SHELL TRIAL WERE BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552642 ↗
• MalfunctionFeb 7, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ONE OF THE TABS THAT CLIPS THE POLY TRIAL TO THE HUMERAL SHELL TRIAL WAS BROKEN.. THE SURGEON WAS ABLE TO USE IT FOR THE CASE, SO IT DIDN¿T SLOW HIM DOWN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16314759 ↗