NA 394.41Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982199690), received between Jul 26, 2019 and May 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THEY HAVE A SYNTHES THREADED ROD AND A WASHER SLEEVE THAT IS ATTACHED FIRMLY. THE O.R DEPT WAS NOT ABLE TO REMOVE THIS WASHER FROM THE ROD. THIS REPORT INVOLVES ONE (1) 14.0MM THREADED SPINDLE 330MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517869 ↗
• MalfunctionAug 31, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE UNIVERSAL CHUCK, SCREWDRIVER SHAFT, HAMMER GUIDE, STARDRIVE SCREWDRIVER SHAFT, CANNULATED HEXAGONAL SCREWDRIVER, THREADED ROD AND UNIVERSAL CHUCK WITH T-HANDLE ARE FOUND BROKEN DURING THE INSPECTION OUTSIDE THE SURGERY. PATIENT INVOLVEMENT IS UNKNOWN. THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) 14.0MM THREADED SPINDLE 330MM. THIS REPORT IS 7 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12392787 ↗
• MalfunctionJul 26, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL TIBIA FOR PRIMARY FIXATION OF A FRACTURE. DURING THE SURGERY, IT WAS NOTED THAT THE THREADS ON THE THREADED SPINDLE WERE STRIPPED, SO IT WAS NOT ALLOWING AN UNKNOWN SPINDLE NUT TO SPIN ON THE THREADS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE OTHER BAR THAT WAS IN THE SET. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICES REPORTED: UNKNOWN SPINDLE NUT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8833624 ↗