INHANCE 6200-10-002Recalls & reported problems
Depuy (Ireland) · INHANCE SHOULDER SYSTEM SILHOUETTE RESECTION GUIDE · 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 resection guide is a surgical instrument used to cut bone during shoulder replacement. The 43 reports mostly describe hardware problems during surgery — pins cross-threading or sticking in the guide, stripped threads, metal shavings, and parts bending or breaking — with no deaths and no injuries. Most reports say nothing went wrong with the patient, and in several cases surgery continued as planned. 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
- 44
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 10603295538974), received between Nov 1, 2022 and Sep 22, 2026 — classified as 44 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (26 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
- Device-Device Incompatibility26
- Material Deformation12
- Break9
- Contamination /Decontamination Problem1
- Corroded1
- Improper or Incorrect Procedure or Method1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Contamination /Decontamination Problem
It was reported that the event did not happen in surgery. The representative noticed that the screwdriver was bent. Also noticed a barb inside one of the drill holes of the cutting guide.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849808 ↗MalfunctionJun 5, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION AND IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411523 ↗MalfunctionJun 5, 2026Break; Material 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 25408483 ↗MalfunctionApr 9, 2026Material Deformation
IT WAS REPORTED THAT THE PIN GOT CROSS THREADED IN THE CUT GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830279 ↗MalfunctionApr 9, 2026Material Deformation
IT WAS REPORTED THAT PIN GOT CROSS THREADED IN CUT GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829198 ↗MalfunctionJan 20, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN STUCK IN RESECTION GUIDE. ANOTHER WAS AVAILABLE AND THE CASE PROCEEDED AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123546 ↗MalfunctionDec 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RESECTION PIN WAS STUCK IN THE LOCKING PIN HOLE. NO CASE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23882539 ↗MalfunctionDec 18, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PIN COLD WELDED IN CUT GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23844112 ↗MalfunctionDec 8, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE RESECTION PIN GOT STUCK TO HUMERAL CUT GUIDE. THERE WAS NO IMPACT TO SURGERY TIME, PATIENT WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23748514 ↗MalfunctionOct 31, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PIN SLOTS ON CUT GUIDE HAVE BENT OR WORN ENOUGH TO NOT FIT PINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439228 ↗MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DIVERGENT PIN HOLE ON THE SILHOUETTE RESECTION GUIDE DID NOT ACCEPT A PIN ON AN UNKNOWN DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024942 ↗MalfunctionAug 15, 2025Break; Break
IT WAS REPORTED THAT THE METAL SHAVINGS FROM THE ENHANCE RESECTION GUIDE WHERE THE RESECTION GUIDE PINS GO THROUGH IT INTO THE HUMERAL HEAD. RESECTION GUIDE SHOWING SIGNS OF WEAR. NO SURGERY WAS DELAYED DUE TO THE REPORTED EVENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22817217 ↗MalfunctionJun 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DIVERGENT PIN HOLE DID NOT ACCEPT PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22235603 ↗MalfunctionMay 30, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PRIMARY REVERSE TOTAL SHOULDER ARTHROPLASTY, THE SURGEON ATTEMPTED TO DRILL A RESECTION GUIDE PIN THROUGH THE SILHOUETTE RESECTION GUIDE, AND THE PIN WAS HUNG UP. THERE WERE NO BROKEN PIECES. THERE WAS NO DELAY OR COMPLICATIONS TO THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22113271 ↗MalfunctionMay 22, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT THE RESECTION PIN WAS STUCK IN THE INHANCE CUT GUIDE. USER HIT A SUTURE ANCHOR AND BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22071770 ↗MalfunctionMar 27, 2025Break; Corroded; Break; Corroded
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REPAIR PROCEDURE, AND CORROSION AND METAL SHAVINGS WERE NOTICED ON/NEAR ALIGNMENT HOLES. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21706063 ↗MalfunctionMar 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT A BURR WAS CREATED WHILE DRILLING A RESECTION PIN IN THE CUT GUIDE. NO ONE WAS INJURED. NO DELAY IN SURGERY. SURGEON USED A DIFFERENT HOLE IN THE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21529722 ↗MalfunctionFeb 19, 2025Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE THREADS BROKE.
Patient problems: Insufficient Information
MAUDE report 21411434 ↗MalfunctionJan 24, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE CASE ONE OF THE RESECTION GUIDE PINS BECAME STUCK IN THE CUTTING GUIDE. THE HUMERAL RESECTION WAS MADE AND THE RESECTION GUIDE WAS REMOVED AS ONE PIECE. THIS DID NOT AFFECT SURGICAL TIME. THE GLENOSPHERE INSERTER WAS DIFFICULT TO THREAD ONTO THE HANDLE. THIS ALSO DID NOT AFFECT SURGICAL TIME. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21234639 ↗MalfunctionJan 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE CROSS PIN GOT STUCK. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 21178641 ↗MalfunctionNov 12, 2024Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material
IT WAS REPORTED THAT WHILE DRILLING THE PIN THROUGH A HOLE IN THE RESECTION GUIDE, THE PIN GOT STUCK IN THE HOLE OF THE GUIDE. SURGEON WAS ABLE TO BE CONTINUE THE SURGERY BY UTILIZING THE OTHER HOLES (AVOIDING THE HOLE IN WHICH THE PIN ORIGINALLY STUCK). FOLLOWING THE CASE IT WAS NOTICED THAT THE RESECTION GUIDE HAD SOME MINOR DAMAGE AT THE LOCATION OF THE HOLE. THE ISSUE WAS THAT THE PIN WAS BEING CUT INTO BY THE DAMAGED METAL SLOT OF THE GUIDE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665466 ↗MalfunctionOct 30, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT CUTTING GUIDE WOULD NOT ACCEPT PINS AND SEEMS WARPED. XS HUMERAL SIZER BROKE, L AND XL GLENOID SIZER ALSO BROKE.
Patient problems: Insufficient Information
MAUDE report 20571534 ↗MalfunctionSep 20, 2024Break; Break
IT WAS REPORTED THAT THE RESECTION GUIDE IS STARTING TO CHIP AND HAS SHARP EDGES. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20268999 ↗MalfunctionJun 20, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN COLD WELDED INTO CUT GUIDE WHEN USING DIVERGENT PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19575292 ↗MalfunctionMay 28, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN GOT STUCK IN GUIDE.
Patient problems: Insufficient Information
MAUDE report 19403852 ↗
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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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