AUTOFIX 141-2022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700586900820), received between Aug 5, 2020 and Nov 9, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2020Fracture; Fracture

  CUSTOMER REPORTED THAT : "DURING THE INSTALLATION OF TWO AUTOGRADE SEPTOID SCREWS WITHOUT STRESS ON THE INSTALLATION, FRACTURE OF THE DISTAL THREAD AND BURSTING OF THE 2 SCREWS. PERSISTENCE OF METAL IN THE PROXIMAL AREA OF THE SCAPHOID, NEED TO PLACE ANOTHER MATERIAL." ADDITIONALLY REPORTED: 30 MINUTE SURGICAL DELAY. IMPOSSIBLE TO REMOVE THE THREAD BECAUSE IT HAS EXPANDED INTO THE BONE AND THERE IS A DANGER OF DAMAGING THE PROXIMAL POLE OF THE SCAPHOID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10813433 ↗
• MalfunctionAug 5, 2020Fracture; Fracture

  CUSTOMER REPORTED THAT : "DURING THE INSTALLATION OF TWO AUTOGRADE SEPTOID SCREWS WITHOUT STRESS ON THE INSTALLATION, FRACTURE OF THE DISTAL THREAD AND BURSTING OF THE 2 SCREWS. PERSISTENCE OF METAL IN THE PROXIMAL AREA OF THE SCAPHOID, NEED TO PLACE ANOTHER MATERIAL." ADDITIONALLY REPORTED: 30 MINUTE SURGICAL DELAY, IMPOSSIBLE TO REMOVE THE THREAD BECAUSE IT HAS EXPANDED INTO THE BONE AND THERE IS A DANGER OF DAMAGING THE PROXIMAL POLE OF THE SCAPHOID.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10370109 ↗
• MalfunctionAug 5, 2020Fracture; Fracture

  CUSTOMER REPORTED THAT : "DURING THE INSTALLATION OF TWO AUTOGRADE SEPTOID SCREWS WITHOUT STRESS ON THE INSTALLATION, FRACTURE OF THE DISTAL THREAD AND BURSTING OF THE 2 SCREWS. PERSISTENCE OF METAL IN THE PROXIMAL AREA OF THE SCAPHOID, NEED TO PLACE ANOTHER MATERIAL." ADDITIONALLY REPORTED: - 30 MINUTE SURGICAL DELAY - IMPOSSIBLE TO REMOVE THE THREAD BECAUSE IT HAS EXPANDED INTO THE BONE AND THERE IS A DANGER OF DAMAGING THE PROXIMAL POLE OF THE SCAPHOID

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10369327 ↗