INHANCE 6500-10-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295547242), received between Dec 7, 2023 and Apr 8, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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.

• MalfunctionApr 8, 2026Material Deformation

  IT WAS REPORTED THAT THE INHANCE DEPTH GAUGE HAD A KINKED TIP IMMEDIATELY ADJACENT TO THE HOOK; THE VERY END TIP WAS BENT RATHER THAN STRAIGHT. THE EVENT DID NOT OCCUR IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818772 ↗
• MalfunctionOct 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT WHEN KITTING THE INSTRUMENT SET, THE PRODUCT IN QUESTION WAS FOUND TO BE BENT UPON OPENING. THE PRODUCT IN QUESTION HAS NOT BEEN SHIPPED. NO FURTHER INFORMATION IS AVAILABLE. THE PRODUCT WAS RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348091 ↗
• MalfunctionMay 30, 2025Material Discolored; Material Deformation; Material Discolored; Material Deformation

  IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON NOTED THAT THE DEPTH GAUGE WAS SLIGHTLY BENT AND THE LASER LINES WERE FADED. THERE WERE NO BROKEN PIECES. THERE WAS NO DELAY OR COMPLICATION TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113021 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE TIP WAS BROKE OFF.

  Patient problems: Insufficient Information

  MAUDE report 20928936 ↗
• MalfunctionOct 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE DEPTH GAUGE WAS BENT. THERE WERE NO BROKEN PIECES. THERE WERE NO DELAYS OR COMPLICATIONS TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345318 ↗
• MalfunctionMar 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE DEPTH GAUGE WAS BENT BEYOND REPAIR. THE INSTRUMENT WAS REMOVED ENTIRELY FROM THE PATIENT, ALL PIECES WERE COLLECTED, AND THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866166 ↗
• MalfunctionDec 7, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DEPTH GAUGE WAS BENT.

  Patient problems: Insufficient Information

  MAUDE report 18282765 ↗