Peri-Loc 71173400Recalls & reported problems
Smith & Nephew, Inc. · PERI-LOC TARGETER 4.5MM DISTAL FEMUR HANDLE LEFT · Class 2
All models of Peri-Loc (102)
Data updated Oct 16, 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 03596010538512), received between Apr 8, 2019 and Jan 25, 2021 — classified as 2 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 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 25, 2021Break; Break
IT WAS REPORTED THAT THE TARGETER 4.5MM DF HANDLE LEFT IT IS BROKEN. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN IF THERE WAS A CASE INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11226451 ↗MalfunctionApr 8, 2019Break; Break
IT WAS REPORTED THAT DURING USE THE DEVICE BROKE WHERE THE SCREWS GO IN DUE TO BEING OVER TIGHTENED. NO PIECES FELL INTO THE PATIENT'S WOUND OR INCISION. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8493438 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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