NA 201-78-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885862045195), received between Apr 4, 2022 and Apr 4, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED FROM OUS THAT DURING AN INITIAL ORTHOPEDIC SURGERY THE HOLDING PIN BROKE. THERE WERE NO PIECES OF THE BROKEN DEVICE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH SPARE DEVICES. THE PATIENT WAS STABLE LEAVING THE OPERATING ROOM. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994886 ↗
• MalfunctionApr 4, 2022Break; Break

  IT WAS REPORTED FROM OUS THAT AFTER USE OF PINS IN AN ORTHOPEDIC SURGICAL CASE THE HEAD OF THE PINS WERE NOTED TO BE BROKEN. ALL PIECES OF THE PINS WERE ACCOUNTED FOR, NO PIECES FELL INTO THE SURGICAL SITE. THE PATIENT WAS STABLE AFTER SURGERY. THE REPRESENTATIVE WAS PRESENT AT TIME OF SURGERY. MULTIPLE EMAIL REQUESTS WERE SENT TO THE CONTACTS FOR ADDITIONAL INFORMATION. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE CONTACTS RELATED TO THIS EVENT. 1 OF 2 MDRS FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994827 ↗