K15-PORK 71434713Recalls & reported problems
Smith & Nephew, Inc. · POROUS TIBIA FIN PUNCH GUIDE SZ 5-6 · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556744567), received between Dec 3, 2024 and May 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Break; Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE BOLT AND SPRING THAT HOLD THE CONNECTING PIECES OF ONE (1) POROUS TIBIA FIN PUNCH GUIDE SZ 5-6 BROKE. THE PROCEDURE WAS RESUMED AFTER A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH & NEPHEW BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21997444 ↗MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A TKA SURGERY, THE SCREW AND SPRING FROM ONE (1) POROUS TIBIA FIN PUNCH GUIDE SZ 5-6 FELL OUT. NOTHING FELL INTO THE WOUND. THE SCREW NOW DOES NOT FIT FLUSH AND MAY FALL OUT AGAIN. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20838541 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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.
How reports and recalls are matched · Editorial policy · Report an error on this page