SIGMA LCS HIGH PERFORMANCE 9505-02-014Recalls & reported problems
Depuy Orthopaedics, Inc. · SIGMA LCS HIGH PERFORMANCE MBT KEEL PUNCH NONCEMENTED SIZE 2-3 · Class 1
All models of SIGMA LCS HIGH PERFORMANCE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295227342), received between Apr 18, 2018 and Jan 5, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Most reported problems
Device problems
- Break2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2022Break; Break
IT WAS REPORTED THAT THE DEVICE MBT PUNCH WAS HIT WITH A MALLET W/ OUT A HANDLE ATTACHED. SMALL METAL PIECE BROKE OFF. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169356 ↗MalfunctionApr 23, 2021Break; Break
IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND IN SET BROKEN. NOT TURNED IN FOR CARE. METAL TAB IS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11713361 ↗MalfunctionApr 18, 2018Naturally Worn; Naturally Worn
IT WAS REPORTED DUE TO WEAR OF THE POST ON THE KEEL PUNCHES, THE KEEL PUNCH IMPACTOR HANDLE SLIPS AND LOOSENS DURING SURGERY. IT GETS DIFFICULT TO REMOVE THE KEEL PUNCH WHEN FINISHED PREPARING TIBIA.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7440468 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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