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EVOS 71174904Recalls & reported problems

Smith & Nephew, Inc. · 1.5MM PROVISIONAL FIXATION PIN 20MM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556386491), received between Dec 26, 2022 and Dec 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 26, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING A FIBULA AND TIBIA OSTEOSYNTHESIS, UPON FASTENING THE PLATE, A 1.5MM PROVISIONAL FIXATION PIN 20MM BROKE OFF WHILE IT WAS REMOVED AND A PART OF IT REMAINED INSIDE THE PATIENT. THIS PART WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S INCISION. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. THE PATIENT WAS REPORTED IN AN STABLE CONDITION UPON PROCEDURE COMPLETION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16048711 ↗

Other PIN, FIXATION, THREADED devices

All PIN, FIXATION, THREADED devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.