NA 5150-9-960Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327093308), received between Jul 31, 2020 and Jul 31, 2020 — classified as 1 malfunction.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 31, 2020Fracture; Fracture

  THE SURGEON PLACED 2X 3MM APEX PINS IN THE LEFT 2ND METACARPAL AND MIDWAY IN THE RADIUS. THE TRIAX MONOTUBE FROM A STERILE WRIST KIT WAS PLACED OVER THE PINS. THE SURGEON REDUCED THE FRACTURE AND TIGHTENED THE BOLTS ON THE PROXIMAL PIN CLAMP FOLLOWED BY THE BOLTS ON THE DISTAL PIN CLAMP. THE PIN CLAMP ON THE DISTAL PINS WAS LOOSENED TO MAKE FURTHER ADJUSTMENTS THEN ALL BOLTS WERE TIGHTENED AGAIN. ONCE THE SURGEON TRIED TO LOOSEN THE FLEXION/EXTENSION CONTROL ON THE DISTAL PIN CLAMP, THE BOLT BROKE. A PORTION OF THE BOLT REMAINED IN THE PIN CLAMP AND ANOTHER PORTION ALONG WITH THE HEAD OF THE BOLT WAS SEPARATED FROM THE CLAMP. THE 4 APEX PINS WERE REMOVED AND SURGEON SPLINTED THE PATIENT UNDER X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10349716 ↗