NA 702602Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540112774), received between Aug 15, 2022 and Sep 11, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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.

• InjurySep 11, 2026Fracture

  Patient problems: Foreign Body In Patient

  MAUDE report 50739296 ↗
• InjuryJul 18, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE INSTRUMENT BROKE DURING THE PROCEDURE AND THE REST OF THE TAP REMAINS IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22543041 ↗
• MalfunctionJan 25, 2024Break; Fracture; Break; Fracture

  AS REPORTED: "ATTENTION TURNED TO THE OLECRANON. DORSAL INCISION OVER ELBOW MADE AND CARRIED TO THE DORSAL ULNA. THE FRACTURE WAS EXPOSED AND CLEARED OF DEBRIS. THE OLECRANON PROCESS WAS REDUCED TO THE PROXIMAL ULNA. A 2.0MM MINI FRAGMENT PLATE WAS PLACED DORSOLATERALLY TO MAINTAIN THE REDUCTION. WE PROCEEDED TO DEFINITIVE FIXATION WITH THE PLAN TO USE A LARGE 6.5MM CANNULATED SCREW INTRAMEDULLARY. A 2CM SPLIT WAS MADE IN THE DISTAL TRICEPS. A GUIDEWIRE WAS PLACED AND INSERTED IN ANTEGRADE FASHION DOWN THE ULNAR CANAL. IT WAS THEN OVER DRILLED. A 6.5MM TAP WAS INSERTED, BUT UPON INSERTION THE TAP MALFUNCTIONED AND BROKE. THERE WAS NO SAFE WAY TO RETRIEVE THE BROKEN TAP WITHOUT SIGNIFICANT DAMAGE TO THE ULNA. I ELECTED TO ABANDON INTRAMEDULLARY FIXATION AND PERFORM PLATE FIXATION DEFINITIVELY TO THE OLECRANON. A 2.7MM MINI FRAGMENT PLATE WAS SELECTED AND BENT TO CONTOUR THE PROXIMAL ULNA. IT WAS APPLIED DORSALLY. A COMBINATION OF BOTH LOCKING AND NON-LOCKING SCREWS WERE PLACED PROXIMALLY AND DISTALLY TO THE FRACTURE. THE BROKEN TAP WAS LEFT IN PLACE SINCE IT WAS WELL FIXED AND CONTAINED WITHIN BONE. FINAL FLUOROSCOPIC IMAGES OBTAINED."

  Patient problems: Foreign Body In Patient

  MAUDE report 18578738 ↗
• MalfunctionAug 15, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT "DURING AN OPERATION FOR A FRACTURE OF THE NECK OF THE RIGHT FEMUR, THE SURGEON DID NOT FEEL THE TAP BREAK DURING HIS OPERATION. HE NOTICED IT DURING THE SCAN. AS AN IMMEDIATE SOLUTION, HE TRIED TO REMOVE IT, WITHOUT SUCCESS. HE THEREFORE LEFT IT IN PLACE AND CHANGED HIS AIM TO PLACE TWO OTHER NECK SCREWS. THE FRAGMENT OF THE TAP THAT REMAINED IN PLACE CAN BE SEEN ON THE RADIOGRAPH." THE PROCEDURE WAS DELAYED BY 60 MIN.

  Patient problems: Foreign Body In Patient

  MAUDE report 15223429 ↗