SIGMA 2024-99-111Recalls & reported problems
Depuy (Ireland) · SIGMA HP PARTIAL KNEE-UNI/TROCHLEA SYSTEM HANDLE · Class 1
All models of SIGMA (380)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Sigma HP handle is a manual surgical instrument used in partial knee surgery. Its 79 reports, with no deaths and no injuries, all describe malfunctions, mostly the handle breaking, failing to lock or release, or getting stuck. Some reports say the handle came loose or broke during surgery, and in one case another handle from the tray was used. 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
- 79
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 79 adverse event reports that list this exact device (DI 10603295084174), received between Jul 12, 2017 and Apr 23, 2025 — classified as 79 malfunctions.
The most frequently reported specific device problem is “Break” (34 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break34
- Device-Device Incompatibility18
- Mechanical Jam10
- Unintended Movement9
- Difficult to Open or Close7
- Naturally Worn7
- Appropriate Device Problem Term/Code Not Available3
- Connection Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient30
- No Information9
- Insufficient Information3
- No Code Available1
Recent adverse event reports
The 25 most recent of 79 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT HANDLE DID NOT STAY CLIPPED INTO THE INSTRUMENTATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY IN SURGERY BECAUSE USER HAD ANOTHER HANDLE IN THE TRAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21893168 ↗MalfunctionJan 27, 2025Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED STATES THAT THE HANDLE DID NOT BREAK INTO MULTIPLE PIECES. I'M NOT SURE WHAT BROKE, BUT THE HANDLE NO LONGER LOCKS INTO POSITION/RETAINS A CUT BLOCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21241465 ↗MalfunctionSep 23, 2024Mechanical Jam; Mechanical Jam
THE INSTRUMENT´S LOCKING MECHANISM CANNOT BE OPENED, IT IS STUCK.
Patient problems: Insufficient Information
MAUDE report 20283038 ↗MalfunctionAug 28, 2024Material Integrity Problem; Mechanical Jam; Material Integrity Problem; Mechanical Jam
IT WAS REPORTED THAT THE INSTRUMENT DOES NOT FUNCTION CORRECTLY. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20092264 ↗MalfunctionMay 1, 2024Break; Break
SIGMA HP SYSTEM HANDLE BROKE WHILE SURGEON WAS ATTACHING IT TO THE CUTTING BLOCK.
Patient problems: Insufficient Information
MAUDE report 19220459 ↗MalfunctionApr 18, 2024Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19132846 ↗MalfunctionApr 15, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
THE SPRING THAT RELEASES THE HANDLE NO LONGER WORKS STRONGLY ENOUGH, SO THE HANDLE CANNOT BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19112295 ↗MalfunctionFeb 28, 2024Break; Break
IT WAS REPORTED THAT THE SURGEON WAS PREPARING DISTAL FEMORAL CUT WITH THE SYSTEM HANDLE ATTACHED TO THE DISTAL CUTTING BLOCK AND IT BROKE INTO 3 PIECES. FIVE MINUTE DELAY WHILST RETRIEVING BROKEN FRAGMENTS. PROCEDURE PRECEDED AS PLANNED, AS THERE WAS A SECOND SYSTEM HANDLE ON THE TRAY. THERE WAS NO CONSEQUENCE TO THE PATIENT DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796476 ↗MalfunctionDec 27, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT SYSTEM HANDLE HAS BEEN USED FOR A HUGE NUMBER OF CASES AND THE INSTRUMENT HAS WORN AND IS NO LONGER FUNCTIONING WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? NO. EVENT OUTCOME/HOW WAS IT MANAGED? PROCEDURE CARRIED ON WITHOUT ANY ISSUES. WAS THERE ANY CONSEQUENCE TO THE PATIENT DUE TO THE EVENT? NO. WAS THE SURGERY PROLONGED DUE TO THE EVENT? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? NO. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE SYSTEM HANDLE HAS BEEN USED FOR A HUGE NUMBER OF CASES AND THE INSTRUMENT HAS WORN AND IS NO LONGER FUNCTIONING AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18400175 ↗MalfunctionDec 22, 2023Break; Break
IT WAS REPORTED THAT WHILE TRYING TO POSITION THE FEMORAL CUTTING BLOCK WITH THE HOLDING HANDLE, THE CONNECTION TIP BROKE OF THE HANDLE AND THE HANDLE SEPARATED FROM THE BLOCK. THE BROKEN TIP WAS RETRIEVED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18382388 ↗MalfunctionNov 13, 2023Break; Break
IT WAS REPORTED THAT TIP OF THE UNIVERSAL HANDLE THAT ENGAGES CUT BLOCKS BROKE OFF. ALL PIECES WERE RETRIEVED AND THERE WAS NO SURGICAL DELAY OR ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124462 ↗MalfunctionSep 6, 2023Break; Break
DURING DISASSEMBLY, THE LOCKING LUGS BROKE OFF. INSTRUMENT FRACTURED INTO TWO OR MORE PIECES. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY. NO FRAGMENT ENTERED THE SURGICAL AREA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690192 ↗MalfunctionMar 16, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE SIGMA HP UNI FEMORAL BLOCK HOLDING INSTRUMENT WOULD NOT RELEASE OFF OF FEMORAL CUTTING BLOCK. A NEW ONE WAS OPENED FOR SURGEON. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553585 ↗MalfunctionNov 21, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE HANDLE BROKEN, WON'T CONNECT. NO PIECES BROKE OFF JUST LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15837283 ↗MalfunctionNov 8, 2022Break; Break
ADDITIONAL INFORMATION RECEIVED. A. WHAT PART OF THE INSTRUMENT BROKE? HANDLE. B. DID IT BREAK INTO TWO OR MORE PIECES? IF NO, PLEASE SPECIFY WHAT IS THE ALLEGED DEFICIENCY, IS IT BENT, CRACKED, STRIPPED, SCRATCHED, WORN OR CROSS THREADED? THE EDGE SNAPPED OFF. C. WERE ALL PIECES OF THE BROKEN INSTRUMENT RETRIEVED FROM THE PATIENT? YES. D. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, WHAT WAS THE DURATION OF THE DELAY? NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15752648 ↗MalfunctionNov 2, 2022Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam
IT WAS REPORTED THAT THE HANDLE IS JAMMED. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714600 ↗MalfunctionNov 2, 2022Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714264 ↗MalfunctionOct 20, 2022Structural Problem; Structural Problem
IT WAS REPORTED THAT THE HANDLE WOULD NOT STAY LOCKED. NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15638638 ↗MalfunctionSep 12, 2022Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT THE HANDLE ON INSTRUMENT IS FAULTY AND DOES NOT CLOSE PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15401736 ↗MalfunctionSep 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE HANDLES ARE LOOSE AND NO LONGER ENGAGING WITH TIBIAL BASE PLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15372078 ↗MalfunctionSep 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE HANDLES ARE LOOSE AND NO LONGER ENGAGING WITH TIBIAL BASE PLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371855 ↗MalfunctionSep 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE HANDLES ARE LOOSE AND NO LONGER ENGAGING WITH TIBIAL BASE PLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371800 ↗MalfunctionSep 7, 2022Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE HANDLES ARE LOOSE AND NO LONGER ENGAGING WITH TIBIAL BASE PLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371719 ↗MalfunctionAug 29, 2022Break; Break
IT WAS REPORTED THAT THE INSTRUMENT IS BROKEN. THERE WAS A UNKNOWN SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15310928 ↗MalfunctionAug 12, 2022Naturally Worn; Naturally Worn
IT WAS REPORTED THE HANDLE LOCKING MECH IS WORN. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217221 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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