Peri-Loc 71173550Recalls & reported problems
Smith & Nephew, Inc. · LARGE FRAGMENT GUIDE REMOVAL ASSEMBLY · Class 2
All models of Peri-Loc (102)
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 03596010519566), received between Feb 8, 2022 and Sep 14, 2022 — 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.
Most reported problems
Device problems
- Break1
- Fracture1
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.
MalfunctionSep 14, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TEETH ON THE LG FRAG GUIDE REMOVAL ASSEMBLY HAVE BROKEN OFF. NO PIECES FELL INTO THE PATIENT. SURGERY WAS FINISHED WITHOUT ANY DELAY WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15423126 ↗MalfunctionFeb 8, 2022Break; Break
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A LARGE FRAGMENT GUIDE REMOVAL ASSEMBLY BROKE. IT IS UNKNOW IF ANY PIECES FELL INSIDE OF THE PATIENT. ALSO, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED OR IF THERE WAS ANY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13478805 ↗
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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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