NA 1806-4290Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540196880), received between Jul 29, 2019 and Aug 15, 2025 — 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.

• MalfunctionAug 15, 2025Break; Fracture; Break; Fracture

  AS REPORTED: "THIS E-MAIL IS TO INFORM YOU OF AN INCIDENT THAT OCCURRED WITH A Ø4,2MM LG 230MM QUICK-RELEASE BIT REFERENCE 1806-4290. DURING FEMORAL NAILING, THE FIRST DISTAL LOCKING SCREW WAS CORRECTLY INSERTED. DURING DRILLING FOR THE 2ND LOCKING SCREW, THE DRILL BIT BROKE OFF INTEROSSEOUSLY AND THE BROKEN PART REMAINED IN THE BONE, WITH NO CONSEQUENCES FOR THE PATIENT FOR THE TIME BEING. THE REMAINING PART OF THE DRILL BIT WAS PRE-DISINFECTED AND WASHED. IT HAS BEEN REMOVED FROM THE ANCILLARY EQUIPMENT AND IS AT YOUR DISPOSAL FOR EXPERT APPRAISAL." ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER ON JULY 23, 2025: "1. HOW WAS THE EVENT DETECTED? DURING THE INSERTION OF THE SECOND SCREW. THE SURGEON NOTICED THAT THE INSERTION WAS NOT GOING WELL AND WHEN HE REMOVED THE DRILL BIT, A PIECE WAS MISSING. 2. DID THE EVENT OCCUR DURING THE PROCEDURE? YES! A. IF YES: WAS THE PROCEDURE COMPLETED SUCCESSFULLY? YES, EXCEPT THAT THE SURGEON WAS UNABLE TO INSERT A SECOND DISTAL FIXATION SCREW. 3. WAS THE PROCEDURE DELAYED? NOT PARTICULARLY. 4. WAS ADDITIONAL MEDICAL INTERVENTION NECESSARY? NO, FOR THE TIME BEING, THE SURGEON HAS DECIDED TO LEAVE THE PIECE OF WICK IN THE BONE AND MONITOR IT."

  Patient problems: Foreign Body In Patient

  MAUDE report 22821595 ↗
• MalfunctionJul 29, 2019Break; Entrapment of Device

  DURING THE JALANE INTERLOCKING SURGERY OF MEDULLARY REDUCTION, WHEN THE PARTIAL PERFORATION IS MADE DISTAL BLOCK. THE 4.2 MM BROCA IS BROKEN AND THE SMALLEST PART REMAINS INSIDE THE PATIENT, WHICH CAN NOT BE REMOVED. THE REMAINING FRAGMENT IS DELIVERED TO TECHNOVIGILANCE OF THE HOSPITAL. BROKEN DRILL FRAGMENT REMAINS INSIDE THE PATIENT AS THERE WAS NO WAY TO REMOVE DURING THE SURGERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8838009 ↗