INHANCE 6205-10-101Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM 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 impactor handle is a hand tool used during shoulder surgery to drive the implant into place. The 59 reports describe the handle wearing out naturally, threads deforming or cross-threading, parts bending or breaking off during set-up and cleaning, and pieces becoming cold-welded together so they could not be unscrewed. Most events happened outside the patient, with no injuries reported. 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
- 58
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10603295539384), received between Oct 5, 2022 and May 13, 2026 — classified as 58 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (24 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 Worn24
- Material Deformation18
- Break17
- Device-Device Incompatibility10
- Contamination /Decontamination Problem1
- Material Integrity Problem1
- No Apparent Adverse Event1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Material Deformation
IT WAS REPORTED THAT DURING A PROCEDURE THE IMPACTOR HANDLE AND ROD CROSS-THREAD. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25164349 ↗MalfunctionMay 5, 2026Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY. DURING FOLLOW UP WITH THE REPORTER IT WAS STATED THAT THE INHANCE IMPACTOR HANDLE AND GLENOSPHERE ADAPTER THREADED TOGETHER WITH MUCH DIFFICULTY. WHEN THE USER TRIED TO UNSCREW THE TWO PIECES, THEY HAD BECOME COLD WELDED TOGETHER AND COULD NOT BE SEPARATED. IT WAS ALSO OBSERVED THAT THE HEAD OF THE 20 DRIVER WAS ROUNDED OFF AND NEEDED TO BE REPLACED. THESE ITEMS WERE NOT USED IN THE CASE AS WE HAD DONE AN ANATOMIC SHOULDER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086971 ↗MalfunctionApr 27, 2026Material Deformation
IT WAS REPORTED THAT THE DEVICE HAD STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999756 ↗MalfunctionApr 17, 2026Break
IT WAS REPORTED THAT THE IMPACTOR HANDLE'S THREADED PART BROKE OFF, AND THE WHITE IMPACTOR TIP CRACKED. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AS THE EVENT OCCURRED DURING SET-UP OR CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24915631 ↗MalfunctionMar 3, 2026Material Deformation
IT WAS REPORTED THAT UPON IMPACTION OF THE GLENOSPHERE TO THE BASE PLATE THE IMPACTOR BENT AT THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24497546 ↗MalfunctionMar 2, 2026Break
IT WAS REPORTED THAT THE IMPACTOR HANDLE'S THREADED PART BROKE OFF, AND THE WHITE IMPACTOR TIP CRACKED. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT, AS THE EVENT OCCURRED DURING SET-UP OR CLEANING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24488858 ↗MalfunctionJan 29, 2026Material Integrity Problem
IT WAS REPORTED THAT THREADS WERE DAMAGED AFTER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24209520 ↗MalfunctionJan 27, 2026Break; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES IT DID NOT BREAK INTO PIECES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24189792 ↗MalfunctionDec 16, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THREADS ON INSERTER WERE NOT ALLOWING FOR IMPACTOR TO FULLY SEED AND AS A RESULT IT WAS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821329 ↗MalfunctionNov 24, 2025Material Deformation; Material Deformation
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO GLENOID INSERTERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630711 ↗MalfunctionNov 24, 2025Material Deformation; Material Deformation
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT TWO GLENOID INSERTERS WERE STRIPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23630708 ↗MalfunctionAug 13, 2025Break; Break
IT WAS REPORTED THAT THE IMPACTION HANDLE THREADS GOT SNAPPED OFF INTO THE LARGE IMPACTOR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22793756 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE IMPACTORS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720334 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE IMPACTORS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720327 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE IMPACTORS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720324 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE IMPACTORS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720323 ↗MalfunctionAug 5, 2025Break; Break
IT WAS REPORTED THAT THE INHANCE IMPACTORS ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720320 ↗MalfunctionJun 10, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GLENOID INSERTER TIP STRIPPED POSSIBLY THE HANDLE AS WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22175219 ↗MalfunctionMay 26, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE IMPACTOR WAS CROSS THREADED AND STRIPPED WITH THE IMPACTOR TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084462 ↗MalfunctionMay 14, 2025Break; Break
IT WAS REPORTED THAT THESE PARTS BROKE DURING SURGERY AND NEED TO BE REPLACED.
Patient problems: Insufficient Information
MAUDE report 22017979 ↗MalfunctionMay 13, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GLENOSPHERE IMPACTOR HANDLE (X2) WAS STRIPPED. THE SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012828 ↗MalfunctionMay 12, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE GLENOSPHERE IMPACTOR HANDLE (X2) WAS STRIPPED. THE SURGICAL DELAY IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003692 ↗MalfunctionApr 1, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE DEVICE THREADS WERE FOUND STRIPPED ON THE HANDLE. THIS DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21745062 ↗MalfunctionMar 24, 2025Break; Break
IT WAS REPORTED THAT THREADS ON IMPACTOR HANDLE WERE BROKEN FROM GLENOSPHERE IMPACTION.
Patient problems: Insufficient Information
MAUDE report 21678465 ↗MalfunctionMar 21, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT INSERTION HANDLE THREADS STRIPPED.
Patient problems: Insufficient Information
MAUDE report 21662447 ↗
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