NA 03.133.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982269904), received between Jan 2, 2025 and Jun 12, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THE PERIOSTEAL ELEVATOR CURVED BLADE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488116 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE DRIVER COLLET SNAPPED, RESULTING IN LOOSE CONNECTION (X2), WILL NO LONGER HOLD DRIVERS. THE UNIVERSAL SCREWDRIVER HANDLE TIPS (X2) HAVE CHIPPED AND SHARPENED. THESE ARE UNABLE TO BE USED. THE SCREW DRIVER/CANNULATED/XL25 DRIVER AND RETENTION PIN BECAME BOUND, AND PIN IS UNABLE TO BE REMOVED. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057587 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE PERIOSTEAL ELEVATOR 6MM CURVED BLADE DRIVER COLLET SNAPPED, RESULTING IN LOOSE CONNECTION (X2), WILL NO LONGER HOLD DRIVERS. THE UNIVERSAL SCREWDRIVER HANDLE TIPS (X2) HAVE CHIPPED AND SHARPENED. THESE ARE UNABLE TO BE USED. THE SCREW DRIVER/CANNULATED/XL25 DRIVER AND RETENTION PIN BECAME BOUND, AND PIN IS UNABLE TO BE REMOVED. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057583 ↗