INHANCE 6200-10-003Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM SILHOUETTE RESECTION GUIDE PIN · Class 2
All models of INHANCE (202)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295538981), received between Jul 28, 2022 and Apr 22, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Material Deformation6
- Device-Device Incompatibility3
- Naturally Worn2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information5
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Material Deformation
(B)(4). WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24954158 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24266001 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265998 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265997 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THAT THE IMPACTED PRODUCT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24265996 ↗MalfunctionDec 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT HOSPITAL HAD LOST INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888654 ↗MalfunctionApr 24, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT WHILE SETTING FOR A TOTAL SHOULDER REPLACEMENT CASE ON AN UNKNOWN DATE, THE SILHOUETTE RESECTION GUIDE PIN WOULD NOT ENGAGE THE RESECTION GUIDE, AND APPEARED TO HAVE DAMAGED THREADS. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902307 ↗MalfunctionSep 19, 2024Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: Insufficient Information
MAUDE report 20263308 ↗MalfunctionSep 19, 2024Break; Break
IT WAS REPORTED THAT INSTRUMENTS BROKE.
Patient problems: Insufficient Information
MAUDE report 20261318 ↗MalfunctionJun 7, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT THE ROD IS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19484942 ↗MalfunctionApr 11, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE SILHOUETTE RESECTION GUIDE PIN BECAME CROSS THREADED. THE SMALL HUMERAL DISC SIZER BROKE IN HALF. THIS DID NOT AFFECT THE SURGERY. THE SURGERY WAS NOT DELAYED AND NO ADVERSE AFFECTS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19087108 ↗MalfunctionMar 12, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION WAS RECEIVED. NO SURGERY DELAY. NO ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18889127 ↗MalfunctionFeb 20, 2024Break; Break
IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN DURING SURGERY. SPD RETURNED A BROKEN INHANCE PIN. NOTHING FURTHER TO REPORT. PIN APPEARED TO BE BROKE AS IF IT WAS OVER TIGHTENED IN PIN GUIDE. BROKEN RIGHT BENEATH THE THREADS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18739881 ↗MalfunctionFeb 15, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE PIN GUIDE WILL NOT THREAD INTO RESECTION GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18712788 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.
Patient problems: Insufficient Information
MAUDE report 18597753 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.
Patient problems: Insufficient Information
MAUDE report 18597744 ↗MalfunctionJan 29, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKE DURING SHOULDER REPAIR.
Patient problems: Insufficient Information
MAUDE report 18595332 ↗MalfunctionMay 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED THAT THE ALIGNMENT ROD ON THE SILHOUETTE GUIDE BENT WHILE PLACING INSIDE INCISION AND DOWN HUMERAL SHAFT. ALSO, THE T20 DRIVER WAS USED IMPROPERLY BY THE SCRUB AND CAUSED IT TO STRIP. IT WAS BEING USED IN PLACE OF THE T30 DRIVE WHEN IT SHOULD NOT HAVE BEEN. NO ADVERSE AFFECTS ON THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16862034 ↗MalfunctionJul 28, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT THE SILHOUETTE RESECTION GUIDE PIN APPEARED TO BE BENT AND WAS DISCARDED BY HOSPITAL STAFF. NO DELAY DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15121988 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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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