INHANCE 6201-01-141Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM CANNULATED IMPACTOR HANDLE · Class 1
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy INHANCE Shoulder System cannulated impactor handle has 41 adverse event reports that name its identifier, all describing malfunctions, with no injuries or deaths. Reports mostly describe stripped or broken threads, worn parts, and pieces not disconnecting after washing, sometimes noticed outside surgery. 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
- 40
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295539339), received between Mar 21, 2023 and Jun 22, 2026 — classified as 40 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (12 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 Worn12
- Material Deformation9
- Break8
- Device-Device Incompatibility8
- Material Integrity Problem2
- No Apparent Adverse Event2
- Corroded1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Material Deformation
IT WAS REPORTED THAT IT WAS NOTICED THAT THE THREADS OF THE DEVICE WERE DAMAGED, THEREFORE THE DEVICE WAS REMOVED FROM THE USE. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25577404 ↗MalfunctionJun 5, 2026Break
IT WAS REPORTED THAT BROKEN THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414466 ↗MalfunctionFeb 9, 2026No Apparent Adverse Event
IT WAS REPORTED THAT IT WAS NOTICED THAT THE TIP OF THE HANDLE LOOKS WORN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291906 ↗MalfunctionJan 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE HANDLE AND IMPACTOR TIP WOULD NOT DISCONNECT FROM EACH OTHER AFTER WASHING. THE ISSUE DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24120276 ↗MalfunctionJan 16, 2026Break
INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092403 ↗MalfunctionJan 15, 2026Material Deformation
IT WAS REPORTED THAT THE THREADS ON THE IMPACTOR HANDLE WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24087341 ↗MalfunctionJan 13, 2026Device-Device Incompatibility
IT WAS REPORTED THAT WHILE REASSEMBLING THE INSTRUMENT, THE BLAZER WAS COLD-WELDED TO THE IMPACTOR HANDLE. THE EVENT DID NOT OCCUR DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054318 ↗MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE IMPACTOR HANDLE AND HEAD DISTRACTOR BECAME FUSED TOGETHER DURING SURGERY AND COULD NOT BE SEPARATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897773 ↗MalfunctionDec 18, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE FOUND BROKEN IN TRAY PRIOR TO GOING TO SPD FOR NEXT CASE. THE CASE DID NOT HAPPENED DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23838485 ↗MalfunctionDec 9, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE IMPACTOR HANDLE THREADS/ TIP DAMAGED. BACK UP INSTRUMENTS ON HAND, NO ADDITIONAL SURGERY TIME WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23757125 ↗MalfunctionOct 31, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE THREADS WERE STRIPPED ON THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437471 ↗MalfunctionOct 22, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE STARDRIVER 20 WAS STRIPPED AND COULD NOT TIGHTEN THE SCREW FULLY. THERE WAS A MINOR DELAY OF 10 MINUTES TO THE TOTAL SHOULDER REPLACEMENT CASE TO FIND A REPLACEMENT DRIVER. UPON DECONTAMINATION OF AN IMPACTOR, IT WAS NOTED THAT THE THREADS ON IMPACTOR HAD BEEN DAMAGED. THERE WAS NO DELAY TO THE CASE AS IT WAS FOUND POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23359253 ↗MalfunctionAug 1, 2025Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN WHEN USED IN CONJUNCTION AS A BACK SLAP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22690641 ↗MalfunctionJul 3, 2025Corroded; Mechanical Jam; Corroded; Mechanical Jam
IT WAS REPORTED THAT CANNULA WAS CORRODING IN CANNULATION. PIN WAS STUCK INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22394129 ↗MalfunctionJun 26, 2025Break; Break
IT WAS REPORTED THAT THE SCREWDRIVERS ARE STRIPPED, THE INSERTER HANDLE BROKE, AND THE GLENOID REAMER BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341298 ↗MalfunctionJun 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE IMPACTOR WAS STRIPPED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22142040 ↗MalfunctionApr 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PRIOR TO THE CASE STARTING THE SCRUB TECH NOTICED THAT THE CANNULATED IMPACTOR HANDLE WAS NOT THREADING INTO THE BLAZERS. ANOTHER WAS AVAILABLE AND THE SURGERY PROCEEDED AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21936009 ↗MalfunctionApr 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THREADS ON THE TIPS OF COMPLAINED ITEMS HAD BECOME DAMAGED AND STRIPPED. THESE COMPLAINED INSTRUMENTS WITH THE DAMAGED TIPS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861802 ↗MalfunctionApr 17, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING ROUTINE MEDICAL DEVICE REPROCESSING, MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT THE THREADS ON THE TIPS OF COMPLAINED ITEMS HAD BECOME DAMAGED AND STRIPPED. THESE COMPLAINED INSTRUMENTS WITH THE DAMAGED TIPS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857390 ↗MalfunctionApr 2, 2025Break; Break
IT WAS REPORTED THAT THE CANNULATED IMPACTOR HANDLE TIP BROKE AT THE THREADS.
Patient problems: Insufficient Information
MAUDE report 21756614 ↗MalfunctionMar 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO HANDLES WERE FOUND STRIPPED IN THE SET.
Patient problems: Insufficient Information
MAUDE report 21723841 ↗MalfunctionMar 28, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT TWO HANDLES WERE FOUND STRIPPED IN THE SET.
Patient problems: Insufficient Information
MAUDE report 21723827 ↗MalfunctionMar 11, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE HANDLE THREADS WERE STRIPPED AND NEEDED TO BE REPLACED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 21575399 ↗MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIP OF THE LARGE BOWTIE GLENOID REAMER BROKE WHILE REAMING THE GLENOID. FRAGMENTS WERE GENERATED AND WERE RETRIEVED. THE LARGE BLAZER FUSED ONTO THE CANNULATED HANDLE. THERE WAS NO MISHANDLING OF THE PRODUCT BEFORE OR AFTER ASSEMBLING THE TWO ITEMS. THERE WAS ABOUT A 20 MINUTE TIME DELAY TO TRY TO REMOVE THE BLAZER FROM THE CANNULATED HANDLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158362 ↗MalfunctionDec 5, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20858680 ↗
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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