SPECIALIST 96-6371Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 CEMENTED MODULAR PUNCH SZ 4-5 · Class 1
All models of SPECIALIST (80)
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 10603295248163), received between Feb 9, 2022 and Nov 21, 2023 — 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Naturally Worn2
- Device-Device Incompatibility1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2023Break; Break
ADDITIONAL INFORMATION RECEIVED. A. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? -YES, BUT NOT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18187410 ↗MalfunctionApr 29, 2022Device-Device Incompatibility; Naturally Worn; Unintended Movement; Device-Device Incompatibility; Naturally Worn; Unintended Movement
INSTRUMENT IS BROKEN DUE TO WEAR AND TEAR. IT IS LOOSE AND UNABLE TO BE TIGHTENED AND AT RISK OF FALLING APART WHILST BEING IMPACTED IN THE TIBIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14250369 ↗MalfunctionFeb 9, 2022Break; Naturally Worn; Break; Naturally Worn
IT WAS REPORTED THAT THE INSTRUMENT HAS BROKEN AS PART OF GENERAL WEAR AND TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13497137 ↗
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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