INHANCE INTACT 6231-31-015Recalls & reported problems
Depuy (Ireland) · INHANCE INTACT HUMERAL HANDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295559627), received between Dec 19, 2025 and Mar 31, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE HUMERAL PREPARATION USING THE INTACT INHANCE INSTRUMENTATION SURGEON ADVANCED THE HUMERAL DRIVE SHAFT AND SWITCHED TO POWER ON REAM SETTING TO PREP THE HUMERUS. THE REAMER WOULD NOT ROTATE WHICH RESULTED IN A BENDING OF THE HUMERAL DRIVE SHAFT. THE HUMERAL REAMER BECAME STUCK IN THE HUMERAL HANDLE ALSO. SURGEON THEN SWITCHED TO THE NORMAL INHANCE TECHNIQUE AND COMPLETED THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742924 ↗MalfunctionJan 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT SURGEON COULD NOT GET HUMERAL TEAMING SHAFT TO ALIGN WITH THE REAMER AND BEARING THRU THE HUMERAL FRAME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24117919 ↗InjuryDec 19, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING IMPLANTATION THE STEMLESS COMPONENT ON THE HUMERAL FRAME AND HANDLE ON THE STEMLESS COMPONENT FRACTURED THE ANTERIOR HUMERUS LEADING TO USE OF A STEMMED COMPONENT.
Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 23853922 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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