INHANCE 6500-11-103Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM GLENOSPHERE EXTRACTOR TIP · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a tip used to pull out the glenosphere component during DePuy's InHance shoulder system surgery. The 46 reports mostly describe instruments wearing out, warping, or having stripped or crossed threads so they would not screw onto the matching handle or inserter, along with some parts breaking or stuck together. No deaths and no injuries are reported, and most events happened during instrument checks or case setup rather than in patients. 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
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10603295547259), received between Jan 11, 2023 and Sep 1, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (26 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 Worn26
- Material Deformation19
- Device-Device Incompatibility15
- Break6
- No Apparent Adverse Event4
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543679 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543585 ↗MalfunctionJul 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGICAL PROCEDURE, WHILE THE CUSTOMER WAS CHECKING THE INSTRUMENTS AS USUAL, THE CUSTOMER OBSERVED THAT THE GLENOSPHERE EXTRACTOR WOULD NOT THREAD ONTO THE BASEPLATE INSERTER AND SEEMED TO BE STRIPPED. IT WAS REPORTED THAT THIS HAPPENED POST OP SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT NOR WAS SURGERY TIME DELAYED DUE TO THIS. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE SET AND THE SET REMAINS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785836 ↗MalfunctionDec 19, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING A TOTAL SHOULDER REPLACEMENT PROCEDURE; WHILE PREPPING TO REAM THE HUMERUS DURING CASE SETUP THE TECHNICIAN NOTED THE PLASTIC DRIVER HANDLE END WAS CRACKED AT THE REAMER INSERTION POINT. THE BROKEN DRIVER WAS REPLACED BEFORE THE PATIENT ENTERED THE ROOM. DURING THE PROCEDURE THE SURGEON ATTEMPTED TO REMOVE THE GLENOSPHERE BUT THE EXTRACTOR WOULD NOT THREAD INTO IT AND APPEARED STRIPPED OR DAMAGED. NO OPERATIVE TIME WAS LOST, THERE WERE NO ADVERSE EFFECTS TO THE PATIENT, AND NO INSTRUMENT PARTS REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23853126 ↗MalfunctionDec 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE GLENOSPHERE REMOVAL ADAPTER BECAME COLD WELDED TOGETHER WITH A LARGE STAR DRIVER AND WILL NOT SEPARATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810879 ↗MalfunctionNov 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PRODUCT WAS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617792 ↗MalfunctionOct 17, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE EVENT DID NOT HAPPENED IN SURGERY. BASEPLATE INSERTER ROD, GLENOSPHERE EXTRACTOR TIP, AND STAR 20 NEEDED TO BE REPLACED FROM LOANER TRAY 2 INHANCE GENERAL INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324295 ↗MalfunctionAug 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE THREADS OF THE INSTRUMENT ARE STRIPPED AND IT¿S UNABLE TO SCREW ONTO THE HANDLE. THE EVENT DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22856176 ↗MalfunctionJun 30, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT SEVERAL DEVICES WERE STRIPPED AND ONE INSTRUMENT HAD A BROKEN CLIP PIECE BREAK OFF. THE EVENT DID NOT HAPPEN DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22356529 ↗MalfunctionMay 14, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT AFTER INSERTING THE GLENOSPHERE, THE INSERTER ROD CROSS-THREADED ONTO THE INSERTER TIP. AFTER THE INSERTER TIP WAS REMOVED, THE SALES REPRESENTATIVE NOTICED THE THREADS WERE DAMAGED.
Patient problems: Insufficient Information
MAUDE report 22020244 ↗MalfunctionMay 1, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT INSTRUMENT WAS BENT WHEN REMOVING A GLENOSPHERE. IT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21942656 ↗MalfunctionMar 13, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE INHANCE GLENOID INSERTER TIP BROKE OFF INSIDE THE GLENOSPHERE DURING INSERTION. SURGICAL DELAY WAS UNKNOWN. DOE: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21599402 ↗MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575809 ↗MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575806 ↗MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575804 ↗MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575802 ↗MalfunctionMar 11, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SHOULDER INSTRUMENTS ARE BROKEN, BENT, AND STRIPPED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21575801 ↗MalfunctionJan 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21242911 ↗MalfunctionJan 27, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE INSTRUMENT WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21242904 ↗MalfunctionNov 20, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT'S SHOULDER WAS REVISED. THE EXTRACTION ADAPTERS AND THE STAR DRIVER 20 WERE USED IN AN EFFORT TO REMOVE THE OLD IMPLANTS. THEY WERE DAMAGED IN THE PROCESS OF REMOVING GLENOSPHERE AND HUMERAL SHELL/POLY CONSTRUCTS. THE STAR DRIVER 20 TIP WAS STRIPPED AS WELL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20736584 ↗MalfunctionOct 29, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Device-Device Incompatibility; Material Deformation; Naturally Worn
ADDITIONAL INFORMATION RECEIVED: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - YES. B. PLEASE CONFIRM IF THERE WAS ANY ALLEGED DEVICE DEFICIENCY REPORTED FOR THE GLENOSPHERE EXTRACTOR TIP? -YES THREADS WORN, DIFFICULTY THREADING INTO GLENOSPHERE.
Patient problems: Insufficient Information
MAUDE report 20557568 ↗MalfunctionSep 24, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT DURING THE REMOVAL OF THE GLENOSHERE, THE THREADS ON THE EXTRACTOR GOT CROSS THREADED.
Patient problems: Insufficient Information
MAUDE report 20294670 ↗MalfunctionSep 13, 2024Naturally Worn; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: 2. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. 3. WAS THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20212265 ↗MalfunctionAug 8, 2024Device-Device Incompatibility; Material Deformation; Naturally Worn; Illegible Information; Device-Device Incompatibility; Material Deformation; Naturally Worn; Illegible Information
DURING ROUTINE MAINTENANCE IT WAS DISCOVERED THAT THE GLENOSPHERE INSERTER AND EXTRACTOR PARTS WERE STRIPPED AND WOULD NO LONGER SCREW BACK TOGETHER AS INDICATED IN THE SURGICAL TECHNIQUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19943387 ↗MalfunctionJul 23, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
ADDITIONAL INFORMATION WAS RECEIVED: A. WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? NO. B. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19804612 ↗
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 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page