INHANCE 6205-10-104Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM CONVEX IMPACTOR TIP · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Inhance shoulder convex impactor tip is an impactor tip used in shoulder repair surgery. Reports mostly describe the tip or related instruments breaking, cracking, wearing, or failing to thread during surgery, with no injuries or deaths. There are 40 adverse event reports, no deaths and no injuries. There are no recalls naming this device. Reports rose from 8 in the prior 12 months to 15 in the latest 12 months.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295539414), received between Mar 6, 2023 and Jul 16, 2026 — classified as 39 malfunctions.
The most frequently reported specific device problem is “Break” (22 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
- Break22
- Material Deformation13
- Device-Device Incompatibility8
- Naturally Worn6
- Crack4
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information3
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25846459 ↗MalfunctionJul 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE STAR 20 DRIVER BECAME WORN AND THE SURGEON STRIPPED IT WHILE FINAL TIGHTENING THE PERIPHERAL SCREWS. THE CONVEX IMPACTOR TIP FAILED TO THREAD ONTO THE IMPACTOR HANDLE. INSPECTION SHOWED THE THREADS WERE WORN DOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781253 ↗MalfunctionJun 25, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE ITEM WOULD NOT THREAD INTO THE RESECTION GUIDE. THREADS ARE STRIPED. THE CONVEX HEAD IMPACTOR THREADS ARE STRIPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630965 ↗MalfunctionMay 21, 2026Break
IT WAS REPORTED THAT THE INHANCE GLENOID IMPACTOR TIP BROKE AFTER BEING USED TO IMPACT THE HYBRID GLENOID. THERE WAS NO INJURY OR EFFECT ON THE IMPLANT. ALL PIECES WERE RETRIEVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243380 ↗MalfunctionApr 14, 2026Material Deformation
IT WAS REPORTED THAT THE INHANCE BASEPLATE IMPACTOR IS STRIPPED. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872231 ↗MalfunctionMar 18, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE 48.5X17 HEAD TRIAL HAD TABS THAT WERE BROKEN, SO THE HUMERAL PIN GUIDE WOULD NOT STAY ENGAGED IN THE HEAD TRIAL. DR ASKED THAT HE GET THE HEAD TRIAL REPLACED. ALSO, THE CONVEX IMPACTOR TIP THREAD WAS STRIPPED OUT AND IT WOULD NOT STAY ENGAGED ON THE IMPACTOR HANDLE. DR ASKED THAT HE ALSO HAVE THAT REPLACED. ALL BROKEN PIECES WERE RETRIEVED AND NO DELAYS OR ADVERSE EVENTS TOOK PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24634090 ↗MalfunctionMar 3, 2026Material Deformation
IT WAS REPORTED THAT THE PLASTIC TIP IMPACTOR THREADS WERE CROSS THREADED. THERE WAS NO HARM DONE TO PATIENT AND NO DELAY. ALL PIECES IN TACT. ISSUE WAS FOUND BEFORE CASE STARTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495096 ↗MalfunctionFeb 18, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE THREAD ON THE CONVEX IMPACTOR TIPS WAS STRIPPED, AND THEY WOULD NOT STAY ENGAGED IN THE IMPACTOR HANDLE. THE SURGEON REQUESTED THE REPLACEMENT. THERE WERE NO SURGICAL DELAYS OR ADVERSE EVENTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377908 ↗MalfunctionFeb 18, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY, THE THREAD ON THE CONVEX IMPACTOR TIPS WAS STRIPPED, AND THEY WOULD NOT STAY ENGAGED IN THE IMPACTOR HANDLE. THE SURGEON REQUESTED THE REPLACEMENT. THERE WERE NO SURGICAL DELAYS OR ADVERSE EVENTS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377907 ↗MalfunctionJan 28, 2026Break
IT WAS REPORTED THAT THE IMPACTOR BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202862 ↗MalfunctionJan 22, 2026Break
IT WAS REPORTED THAT THE CONVEX IMPACTOR TIP WAS BROKEN INTO TWO PIECES DURING SURGERY. ALL PIECES WERE RETRIEVED. THE PATIENT WAS NOT AFFECTED AND THERE WAS NO DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24148933 ↗MalfunctionJan 20, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SMALL HUMERAL SIZER WAS CRACKED. THE THREAD ON THE CONVEX IMPACTOR TIP WAS STRIPPED OUT AND IT WAS NOT ENGAGING THE IMPACTOR HANDLE. BOTH PARTS NEED TO BE REPLACED. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. ALL PARTS WERE RETRIEVED. NOTHING WAS LEFT ON FIELD OR IN PATIENT. ACTIVITY LEVEL - YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115610 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. INSTRUMENT BROKE DURING WASH CYCLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850814 ↗MalfunctionNov 4, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE IMPACTOR TIP FOR HUMERAL SHELL AND POLY LINER WAS FOUND TO BE STRIPPED OF THREADS AND UNABLE TO STAY ON THE IMPACTOR HANDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465700 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR TIP SPLIT IN HALF DURING THE CASE. ALL PARTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23341333 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT THE TIP WAS BROKEN OF THE REPORTED INSTRUMENT AND IT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337370 ↗MalfunctionOct 20, 2025Break; Break
IT WAS REPORTED THAT THE TIP WAS BROKEN OFF THE REPORTED INSTRUMENT AND IT NEEDS TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337341 ↗MalfunctionJul 15, 2025Crack; Crack
IT WAS REPORTED THAT THE POLY WAS CRACKED. NO HARM TO PATIENT NOR DELAY IN CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22511870 ↗MalfunctionJun 2, 2025Break; Break
IT WAS REPORTED THAT THE PIECE SNAPPED IN HALF IMPACTING IMPLANT. NO HARM TO PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122412 ↗MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTOR BROKE WHILE IMPACTING THE POLY. THERE WAS NO PATIENT HARM OR TIME EXTENDED IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113042 ↗MalfunctionMar 19, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT DURING THE CASE WHILE THE SURGEON WAS IMPACTING THE FINAL POLY IMPLANT, THE SURGEON WAS OFF AXIS AND GLENOID IMPACTOR CRACKED AT THE THREADS. THERE WAS NO DELAY DUE TO ANOTHER SET BEING AVAILABLE. THE TWO PIECES WERE RETRIEVED, AND THERE WAS NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21646021 ↗MalfunctionJan 13, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT GLENOID IMPACTOR TIP HAD DAMAGED THREADS AND NEEDED TO BE REPLACED. THERE WAS NO TIME DELAY FOR THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21137216 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT THE GLENOID IMPACTOR STARTED TO BREAK/CHIP. ALL PARTS REMOVED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20545293 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533537 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING THIS CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20533523 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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