INHANCE 6205-10-106Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM DRIVER HANDLE · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10603295539438), received between Jun 19, 2023 and Sep 16, 2026 — classified as 22 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 Incompatibility14
- Break5
- Material Deformation3
- Mechanical Jam3
- Illegible Information1
- Material Integrity Problem1
- Structural Problem1
- Unintended Movement1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790562 ↗MalfunctionSep 16, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790557 ↗MalfunctionApr 2, 2026Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT SCREWDRIVER HANDLE COUPLING BECAME STUCK AND WOULD NOT ALLOW A SCREWDRIVER SHAFT TO BE ATTACHED TO IT. ANOTHER WAS USED IN ITS PLACE. SURGICAL TIME WAS NOT EXTENDED AND NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24769593 ↗MalfunctionNov 13, 2025Device-Device Incompatibility; Illegible Information; Device-Device Incompatibility; Illegible Information
ADDITIONAL INFORMATION RECEIVED: UNABLE TO READ LOT NUMBER ON INSTRUMENTS/WORN AWAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23544462 ↗MalfunctionAug 19, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT PRIOR TO CASE, SCRUB NOTICED THE HANDLE ON THE SCREWDRIVER HAD EXCESSIVE MOVEMENT IN THE SHAFT AT THE MALE/FEMALE LOCKING COUPLE FOR ATTACHMENT. SCRUB INFORMED REP THAT IT NEEDED TO BE REPLACED/REPAIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840098 ↗MalfunctionAug 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE BENT PRONGS ON THE STAR DRIVER 20. STRIPPED WHEN USING ON SELF DRILLING SCREWS. REQUESTED FOR REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22708072 ↗MalfunctionJul 21, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE SCREWDRIVER HANDLE WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22561126 ↗MalfunctionJul 9, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER REPAIR ON (B)(6), 2025. THE INHANCE SCREWDRIVER SHAFT WAS GETTING STUCK IN THE SCREWDRIVER HANDLE. IT APPEARS, AFTER CHECKING MULTIPLE DRIVER HANDLES, THAT THIS ONE IS DAMAGED. THERE WAS NO DELAY IN THE CASE AND THE INSTRUMENT IS IN ONE PIECE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22461379 ↗MalfunctionMay 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW DRIVER WAS STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22031899 ↗MalfunctionMay 15, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SCREW DRIVER WAS STRIPPED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22031890 ↗MalfunctionApr 25, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT THE STAR 20 AND GLENOID IMPACTS TIP HAVE COLD WELDED TO EACH OTHER. THE STAR 30 HEAD HAS ROUNDED OUT SCREWDRIVER WON'T LOCK. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21910801 ↗MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SMALL SCREW DRIVER WAS STRIPPED. THE SCREWDRIVER HANDLE WOULD NOT ACCEPT EITHER STAR DRIVER. THE GLENOSPHERE INSERTER WAS STRIPPED AND WOULDN'T ACCEPT THE IMPLANT. THE REAMER SHAFT IS CRACKED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19806413 ↗MalfunctionJul 23, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SMALL SCREW DRIVER WAS STRIPPED. THE SCREWDRIVER HANDLE WOULD NOT ACCEPT EITHER STAR DRIVER. THE GLENOSPHERE INSERTER WAS STRIPPED AND WOULDN'T ACCEPT THE IMPLANT. THE REAMER SHAFT IS CRACKED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19806385 ↗MalfunctionJun 27, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SMALL SCREWDRIVER STRIPPED, REAMER HANDLE CRACKED, SCREWDRIVER HANDLE WOULDN'T ACCEPT STAR DRIVER 30, AND GLENOSPHERE INSERTER IS STRIPPED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19623293 ↗MalfunctionJun 27, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WOULDN'T ACCEPT STAR DRIVER, SMALL SCREWDRIVER WAS STRIPPED, TIP OF THE REAMER HANDLE CRACKED, GLENOSPHERE INSERTER WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 19623176 ↗MalfunctionJun 27, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER HANDLE WOULDN'T ACCEPT STAR DRIVER, SMALL SCREWDRIVER WAS STRIPPED, TIP OF THE REAMER HANDLE CRACKED, GLENOSPHERE INSERTER WAS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 19623168 ↗MalfunctionMay 1, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW DRIVER HANDLE BROKE AND WOULD NOT ACCEPT STAR DRIVER ATTACHMENTS.
Patient problems: Insufficient Information
MAUDE report 19220074 ↗MalfunctionMay 1, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREW DRIVER HANDLE BROKE AND WOULD NOT ACCEPT STAR DRIVER ATTACHMENTS.
Patient problems: Insufficient Information
MAUDE report 19220073 ↗MalfunctionApr 29, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT SCREW DRIVER HANDLE BROKEN. IT WOULD NOT ACCEPT STAR DRIVER ATTACHMENTS.
Patient problems: Insufficient Information
MAUDE report 19200713 ↗MalfunctionApr 29, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT SCREW DRIVER HANDLE BROKEN. IT WOULD NOT ACCEPT STAR DRIVER ATTACHMENTS.
Patient problems: Insufficient Information
MAUDE report 19200712 ↗MalfunctionOct 3, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT HAD A RIGHT REVERSE TSA. THE SCRUB STATED THE HANDLE WAS DIFFICULT TO REMOVE FROM THE SCREWDRIVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17859900 ↗MalfunctionJun 19, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE QUICK CONNECTION WOULDN¿T LOCK THE ATTACHMENTS. NO BROKEN PIECES, NO HARM TO PATIENT, NO SURGERY DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17159519 ↗
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- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 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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