INHANCE 6500-11-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOSPHERE INSERTER TIP · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Inhance inserter tip is a surgical tool used to place parts during shoulder surgery. Its 826 reports describe malfunctions, with no injuries reported. Many describe threads that become cross-threaded or stripped, and parts that wear, deform or break. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 831
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 831 adverse event reports that list this exact device (DI 10603295547266), received between Aug 10, 2022 and Sep 18, 2026 — classified as 831 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (343 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
- Naturally Worn343
- Device-Device Incompatibility312
- Material Deformation312
- Break92
- No Apparent Adverse Event29
- Material Integrity Problem12
- Entrapment of Device3
- Crack2
Patient problems
- No Clinical Signs, Symptoms or Conditions688
- Insufficient Information158
- Foreign Body In Patient2
- Bone Notching1
Recent adverse event reports
The 25 most recent of 831 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819968 ↗MalfunctionSep 17, 2026Device-Device Incompatibility; Material Deformation
It was reported that during a Total Shoulder Replacement surgical procedure, after the insertion of the glenosphere, the baseplate rod and glenosphere inserter tip were cross threaded, and unable to be separated. There was no harm to the patient, no delay in the case.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800536 ↗MalfunctionSep 16, 2026No Apparent Adverse Event
It was reported that the instrument had unknown allegation. It did not happen in surgery.During manufacturer's investigation of the returned device, it was identified that the distal threaded tip broken.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50789647 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721032 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720855 ↗MalfunctionSep 1, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549123 ↗MalfunctionSep 1, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548573 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543511 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543433 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542498 ↗MalfunctionAug 13, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50241404 ↗MalfunctionAug 13, 2026Material Deformation
It was reported that the items have non functioning threads. Additional information received:Cross threaded and/or stripped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233508 ↗MalfunctionAug 13, 2026Material Deformation
It was reported that the items have non functioning threads. Additional information received:Cross threaded and/or stripped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233505 ↗MalfunctionAug 11, 2026Material Deformation
It was reported that during a surgical procedure for shoulder repair it was observed that the threads on the glenoid inserter and the Glenosphere inserter became cross threaded and had stripped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50212378 ↗MalfunctionJul 13, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803288 ↗MalfunctionJul 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785467 ↗MalfunctionJul 6, 2026Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716676 ↗MalfunctionJun 30, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE GLENOSPHERE INSERTOR BOLT WOULD NOT THREAD INTO GLENOSPHERE. THEY TRIED TWO DIFFERENT BOLTS BUT IT JUST KEPT SPINNING AND WOULD NOT THREAD INTO GLENOSPHERE. THEY WERE ABLE TO PLACE IT IN BY HAND AND TIGHTEN IT WITH THE SCREW DRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25664003 ↗MalfunctionJun 19, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE THREADS WERE MESSED UP. PIECES WOULD NOT SCREW TOGETHER, POSSIBLY CROSS THREADED. THE ISSUE WAS CAUGHT BEFORE THE CASE STARTED SO THERE WERE NO DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565727 ↗MalfunctionJun 18, 2026Material Deformation; Material Integrity Problem
IT WAS REPORTED THAT THE DEVICE WAS CROSS THREADED AND DAMAGED PIECES WERE OBSERVED. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555681 ↗MalfunctionJun 17, 2026Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TWO PIECES WOULD NOT THREAD TOGETHER CROSSTHREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25535997 ↗MalfunctionJun 11, 2026Material Deformation
IT WAS REPORTED THAT THE GLENOSPHERE INSERTER TIPS WERE STRIPPED. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473835 ↗MalfunctionJun 11, 2026Material Deformation
IT WAS REPORTED THAT THE GLENOSPHERE INSERTER TIPS WERE STRIPPED. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25473692 ↗MalfunctionJun 10, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A LEFT SHOULDER REPAIR PROCEDURE, WHEN IMPLANTING THE GLENOSPHERE COMPONENT, IT WAS OBSERVED THAT THE GLENOSPHERE INSERTER TIP BROKE OFF IN THE GLENOSPHERE IMPLANT. IT WAS REPORTED THAT THE SURGEON REMOVED THE GLENOSPHERE AND PUT A NEW GLENOSPHERE ON AND USED A NEW TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456705 ↗MalfunctionJun 10, 2026Material Deformation
IT WAS REPORTED6 THAT DURING A SHOULDER REPAIR PROCEDURE IT WAS OBSERVED THAT THE GLENOSPHERE INSERTER TIP WAS CROSS-THREADED WHEN TRYING TO THREAD THE TIP TO THE GLENOSPHERE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456413 ↗
Other Orthopedic manual surgical instrument devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
- NA 03.037.028Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT486 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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