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PIP Fix PFX-426Recalls & reported problems

Hand Biomechanics Lab Inc · External fixation system for dorsal fracture dislocations of the PIP joint. · Class 2 · Implant

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 00861994000243), received between May 14, 2019 and May 14, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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

  • Patient Device Interaction Problem1

Patient problems

  • Bacterial Infection1

Recent adverse event reports

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

  • InjuryMay 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

    PATIENT HAD SURGERY TO INSTALL A PIP FIX EXTERNAL FIXATION SYSTEM. PHYSICIAN REPORTED THAT "PIN TRACT INFECTION REQUIRED DEVICE REMOVAL @ 4 WEEKS POSTOP."

    Patient problems: Bacterial Infection

    MAUDE report 8608748 ↗

Other Component, Traction, Invasive devices

All Component, Traction, Invasive devices →

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