NA 03.505.008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10887587013343), received between Aug 13, 2019 and Aug 4, 2026 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133029 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING CLEANING AFTER THE PROCEDURE, IT WAS FOUND THAT THE GEAR FOR THE 90 DEGREE SCREWDRIVER WAS DAMAGED, THE PLASTIC RING WAS BREAKING AWAY FROM THE GEAR. NOTHING WAS NOTICED DURING THE SURGERY, THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598034 ↗
• MalfunctionFeb 2, 2022Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING INSPECTION ITEMS ARE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) GEAR FOR SCREWDRIVER 90°. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424080 ↗
• MalfunctionAug 13, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN OPEN REDUCTION INTERNAL FIXATION TO THE RIGHT RIBS, THE GEAR FOR SCREWDRIVER POPPED OUT OF THE BACKSIDE OF THE SHAFT HEAD WHEN PRESSURE WAS APPLIED TO THE SCREWDRIVER BLADE. 90¿ WAS BEING USED TO SCREW IN A 12 MM SCREW DURING THE PROCEDURE. WHEN ANALYZED THE GEAR ITSELF SEEMED TO BE TORN UP FROM INNER SHAFT ENGAGING THE THREADS. THE GEAR WAS THEN REINSERTED AND THE CAP WAS TIGHTENED ONTO THE SHAFT AGAIN. ONCE REPAIRED, PRESSURE WAS AGAIN APPLIED AND THE GEAR POPPED OUT OF THE BACKSIDE AGAIN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 15 MINUTES OF SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 12 MM SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1), UNKNOWN SCREWDRIVER BLADE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1), UNKNOWN SHAFT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8889843 ↗