INHANCE 6500-11-102Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM BASEPLATE INSERTER ROD · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy INHANCE shoulder baseplate inserter rod is a surgical tool used in shoulder surgery. Of its 565 reports, all describe malfunctions, most often deformed material, wear and poor fit with other devices. Reports describe tools stripped during shoulder surgery, needing replacement, and cracked handles. No deaths or injuries are recorded, and 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
- 567
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 567 adverse event reports that list this exact device (DI 10603295547235), received between Sep 27, 2022 and Sep 18, 2026 — classified as 567 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (251 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
- Material Deformation251
- Naturally Worn218
- Device-Device Incompatibility208
- Break43
- No Apparent Adverse Event24
- Material Integrity Problem12
- Mechanical Jam5
- Illegible Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions465
- Insufficient Information117
Recent adverse event reports
The 25 most recent of 567 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Device-Device Incompatibility
It was reported that upon inspection of the 32 +0 trial poly, one of the locking tabs was missing. Another set was opened so the surgeon could trial the range of motion. No additional time was added to the surgery, and the broken trial was removed. Another instrument in the tray still had a baseplate attached from a removal surgery performed the week prior. The implant could not be removed, so SPD processed the instrument assembled. The tray was replaced with another tray that was available at the account. All available information has been disclosed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819597 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation
It was reported that while doing a total shoulder replacement with the Inhance instruments, the glenosphere inserter and tip would not screw together. Surgeon believed the threads on each instrument were stripped so he opened another set of instruments and the same thing happened so he need two each of the inserter handle and the inserter tips.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721057 ↗MalfunctionSep 10, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50720996 ↗MalfunctionSep 1, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549113 ↗MalfunctionSep 1, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50548356 ↗MalfunctionSep 1, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543706 ↗MalfunctionJul 13, 2026Device-Device Incompatibility; Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25803289 ↗MalfunctionJul 10, 2026Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785475 ↗MalfunctionJul 6, 2026Material Deformation
IT WAS REPORTED THAT THE DEVICE WAS STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25716682 ↗MalfunctionJul 2, 2026Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR, BOTH DEVICES WERE STRIPPED AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25689971 ↗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 25565896 ↗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 25555695 ↗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 25536000 ↗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 25535994 ↗MalfunctionJun 11, 2026Material Deformation
IT WAS REPORTED THAT THE T20 SCREWDRIVER BROKEN. T30 SCREWDRIVER STRIPPED. IMPACTOR HANDLE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25477961 ↗MalfunctionJun 8, 2026No Apparent Adverse Event
IT WAS REPORTED IT WAS NOTICED CONSIDERABLE WEAR ON THE INSTRUMENTS. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429994 ↗MalfunctionJun 5, 2026Material Integrity Problem
IT WAS REPORTED THAT THE INHANCE T-HANDLE, THREADS ARE BAD. BASEPLATE INSERTER HANDLE, PRIOR TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414015 ↗MalfunctionJun 2, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DRIVER SHAFT WAS CRACKED AT THE DISTAL TIP NEAR COMPRESSION RETAINER CLIPS. IT WAS FURTHER OBSERVED THAT THE T-HANDLE AND GLENO INSERTER TIP CROSS THREADED, WAS ABLE TO SEPARATE, BUT WOULD NOT RE-SEAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365351 ↗MalfunctionJun 2, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE SCREWDRIVER WAS STRIPPED AND THE ADAPTOR AND IMPACTOR HANDLE WERE STUCK TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365163 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THAT THE GLENOSPHERE INSERTER TIP THREADS STRIPPED T-HANDLE MODULAR GLENOIND BASE PLATE AND GLENOSHERE INSERTER THREADS STRIPPED. ADDITIONALLY, 2X STAR 20 SCREW DRIVERS WERE STRIPPED. ALL DEVICES ARE INTACT. NO DELAYS AS THE REPORTER HAVE BACKUP. NO HARM TO PATIENT OR STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351105 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THAT THREADS ARE STRIPPED ON INSERTER. REAMER SHAFT WILL NOT HOLD REAMER. CUT GUIDE PRODUCES METAL SHAVING WHEN PLACING PINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350708 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THAT THREADS ARE STRIPPED ON INSERTER. REAMER SHAFT WILL NOT HOLD REAMER. CUT GUIDE PRODUCES METAL SHAVING WHEN PLACING PINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350707 ↗MalfunctionMay 27, 2026Material Deformation
IT WAS REPORTED THAT THE SCREWDRIVERS HANDLE AND THE INSERTER TIP WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25303577 ↗MalfunctionMay 25, 2026Break; Material Deformation
IT WAS REPORTED THAT THREADS WERE DAMAGED/CROSS THREADED, AND THE PLASTIC PIECE BROKE OFF. THIS EVENT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270801 ↗MalfunctionMay 22, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENT HAD UNKNOWN ALLEGATION. IT WAS FURTHER REPORTED THAT WHILE CHECKING TRAYS AT THE OFFICE, THE TWO PIECES WOULD NOT THREAD TOGETHER. THE FAILURE DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256019 ↗
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
- 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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