NA 398.651Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982201508), received between Feb 13, 2017 and Feb 13, 2017 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 13, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED DURING A TIBIA HARDWARE REMOVAL ON (B)(6) 2016, TWO NARROW SCREW REMOVAL PLIERS WOULD NOT FUNCTION INTRAOPERATIVELY. THE LOCKING MECHANISM APPEARS TO BE NON-FUNCTIONAL IN BOTH INSTRUMENTS. THE PLIERS WERE FROM TWO DIFFERENT SCREW REMOVAL SETS. THE HARDWARE REMOVAL WAS PLANNED WITH NO ALLEGATION OR SERIOUS INJURY AGAINST THE IMPLANTED DEVICES. THE SURGEON USED AN ALTERNATE INSTRUMENT IN ONE OF THE SETS, TO REMOVE THE SCREWS AND HARDWARE. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ALL HARDWARE WAS REMOVED INTACT WITH NO DEVICES LEFT BEHIND IN THE PATIENT. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT DEVICES: SCREW (PART/LOT # UNKNOWN, QTY UNKNOWN). THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6325851 ↗
• MalfunctionFeb 13, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  IT WAS REPORTED DURING A TIBIA HARDWARE REMOVAL ON (B)(6) 2016, TWO NARROW SCREW REMOVAL PLIERS WOULD NOT FUNCTION INTRAOPERATIVELY. THE LOCKING MECHANISM APPEARS TO BE NON-FUNCTIONAL IN BOTH INSTRUMENTS. THE PLIERS WERE FROM TWO DIFFERENT SCREW REMOVAL SETS. THE HARDWARE REMOVAL WAS PLANNED WITH NO ALLEGATION OR SERIOUS INJURY AGAINST THE IMPLANTED DEVICES. THE SURGEON USED AN ALTERNATE INSTRUMENT IN ONE OF THE SETS, TO REMOVE THE SCREWS AND HARDWARE. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND ALL HARDWARE WAS REMOVED INTACT WITH NO DEVICES LEFT BEHIND IN THE PATIENT. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT DEVICES: SCREW (PART/LOT # UNKNOWN, QTY UNKNOWN). THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6325842 ↗