SPECIALIST 96-6360Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 CEMENTED MODULAR PUNCH GUIDE SZ 1.5-3 · Class 1
All models of SPECIALIST (80)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295248101), received between Nov 9, 2021 and Jan 10, 2024 — classified as 4 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
- Detachment of Device or Device Component2
- Naturally Worn1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIN IS MISSING FROM THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484580 ↗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 13497158 ↗MalfunctionDec 14, 2021Break; Break
INSTRUMENT BROKE DURING KNEE SURGERY TODAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13004519 ↗MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INSTRUMENT IS DEFECTIVE, THE LOCKING DEVICE APPEARS TO BE MISSING, SEE BELOW IMAGE OF INSTRUMENT ON THE RIGHT. IT¿S NOT KNOWN WHEN OR HOW THIS DEFECT OCCURRED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12780642 ↗
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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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