NA 03.037.027Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982070432), received between Dec 5, 2018 and Jul 7, 2023 — classified as 1 injury, 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 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.

• MalfunctionJul 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, A DISTRIBUTOR MENTIONED THAT DIRT (DEBRIS) WAS FOUND IN THE HOLLOW OF SEVERAL PRODUCTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE TAP FOR SCREW. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279926 ↗
• MalfunctionMar 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS BROKEN. NO PATIENT INVOLVEMENT WAS REPORTED, AND NO ADVERSE EVENT WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TAP FOR SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573664 ↗
• MalfunctionApr 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISTAL THREADS OF THE TAP FOR SCREW WERE BROKEN. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) TAP FOR SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685639 ↗
• InjuryDec 5, 2018Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL ADVANCE (TFNA) PROCEDURE ON (B)(6) 2018, THE TAP FOR TFNA SCREW BROKE OFF IN THE PATIENT. DURING THE PROCEDURE, THE SURGEON STRUGGLED TO DRILL INTO THE FEMUR NECK, THEN TOOK THE TAP AND STARTED TAPPING. THE TAP BROKE OFF IN THE PATIENT AND THE BROKEN FRAGMENT WAS LEFT IN THE PATIENT. THE SURGEON CLOSED THE PATIENT WITH PLANS TO REVISE AT A LATER DATE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. CONCOMITANT DEVICE: DRILL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TAP FOR SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8134852 ↗