SIGMA HIGH PERFORMANCE 9505-02-050Recalls & reported problems
Depuy (Ireland) · SIGMA HIGH PERFORMANCE FBT KEEL PUNCH - NON CEMENTED SIZE 1.5-3 · Class 1
All models of SIGMA HIGH PERFORMANCE (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295227663), received between May 6, 2019 and Oct 20, 2020 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Device-Device Incompatibility10
Patient problems
- No Consequences Or Impact To Patient10
- No Code Available7
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
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 10706138 ↗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 Consequences Or Impact To Patient
MAUDE report 10706103 ↗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 10705998 ↗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 10705963 ↗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 10705929 ↗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 10705874 ↗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 10705762 ↗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 10700442 ↗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 8584181 ↗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 8584178 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page