SIGMA HIGH PERFORMANCE 9505-02-051Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT KEEL PUNCH - NON CEMENTED SIZE 4-5 · Class 1
All models of SIGMA HIGH PERFORMANCE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295227670), received between May 6, 2019 and Jan 5, 2022 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (13 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.
Most reported problems
Device problems
- Device-Device Incompatibility13
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Consequences Or Impact To Patient11
- No Code Available9
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE LUG HOLE IN FEMUR IS BURNISHED AND CAUSED LUG DRILL TO BIND. KEEL PUNCH WOULD NOT STAY ON HANDLE. NO BROKEN PIECES. NO SURGICAL DELAY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169742 ↗MalfunctionNov 17, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
SCRUB NURSES DURING SET UP OF INSTRUMENT THAT THE RUBBER INSERT INSIDE THE INSTRUMENT WAS MISSING. THIS WAS NOTED BEFORE THE SURGERY STARTED. THE CASE WAS COMPLETED WITH A LIKE INSTRUMENT. NO PIECES WERE LEFT INSIDE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829278 ↗MalfunctionMay 25, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIAL PUNCH WOULD NOT STAY CONNECTED TO TIBIAL HANDLE ANYMORE. THERE WAS NOTHING WRONG WITH THE HANDLE AND THE SURGERY TIME WAS NOT EXTENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11877158 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES WHEN EXTRACTING FROM THE PATIENT. NO SURGICAL DELAY
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10706158 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES DURING EXTRACTION FROM THE PATIENT. NO SURGICAL DELAY
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10706113 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES WHEN BEING EXTRACTED FROM THE PATIENT. NO SURGICAL DELAY
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10706019 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES WHEN BEING EXTRACTED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10705971 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES WHEN BEING EXTRACTED FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10705921 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCH WHEN EXTRACTING PUNCH FROM PATIENT. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10705901 ↗MalfunctionOct 20, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TIBIA PUNCH HANDLE WILL NOT RETAIN PUNCHES DURING EXTRACTION FROM THE PATIENT. NO SURGICAL DELAY.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10705763 ↗MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PUNCH HANDLE WILL NOT RETAIN PUNCHES WHEN EXTRACTING PUNCH FROM THE PATIENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10700426 ↗MalfunctionAug 25, 2020Device-Device Incompatibility; Device-Device Incompatibility
SIGMA TIBIA PUNCH WAS DIFFICULT TO LOAD. ONCE LOADED THE SCRUB NURSE BELIEVED THE PUNCH WAS LOCKED ON TO THE HANDLE BUT ONCE PULLED IT REMOVED EASILY. OTHER PUNCHES IN THE SET WERE LOADED AND THEY WERE SUCCESSFULLY LOADED. ANOTHER SET WAS OPENED AND CORRECT SIZE PUNCH WAS CHOSEN AND LOCKED INTO POSITION ON HANDLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES OR SURGICAL DELAYS.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 10451098 ↗MalfunctionMay 6, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PUNCH HANDLES AND PUNCHES HAVE BEEN REFURBISHED BUT ARE STILL NOT HOLDING THE PUNCH DURING PUNCH EXTRACTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8584177 ↗MalfunctionMay 6, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PUNCH HANDLES AND PUNCHES HAVE BEEN REFURBISHED BUT ARE STILL NOT HOLDING THE PUNCH DURING PUNCH EXTRACTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8584173 ↗
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- DJO SURGICAL 801-05-040Encore Medical, L.P. · PUNCH, SURGICAL1 recall7 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 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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