NA 1806-0083SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540195913), received between Sep 29, 2015 and May 12, 2025 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Break; Fracture; Break; Fracture

  AS REPORTED:"THE SURGEON ASKED FOR A SLIGHT BEND IN THE GUIDE, WHICH ENDED BROKEN IN THE IBODE'S FINGERS." ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003510 ↗
• MalfunctionMar 8, 2019Difficult to Remove; Difficult to Advance; Physical Resistance/Sticking

  DURING PRIMARY PROCEDURE OF LEFT HUMERUS. IT WAS REPORTED THAT WHEN REAMING, THE REAMERS (SIZE 6-8 IN .5MM INCREMENTS) WERE DIFFICULT TO ADVANCE OVER THE 3.0 800MM GUIDE WIRE. SURGEON REAMED TO SIZE 8 AND MOVED TO MODULAR REAMERS TO MORE EASILY REAM. AFTER THE NAIL WAS PLACED WITH THE TARGETER, A SCREW HOLE WAS DRILLED USING THE CANNULA. AFTER DRILLING, HE INSERTED THE FIRST SCREW AND THE CANNULA BECAME STUCK ON THE SCREW HEAD AND WAS DIFFICULT TO REMOVE. THEN THE SECOND PROXIMAL SCREW HOLE WAS DRILLED. AS THE SURGEON ADVANCED THE SCREW DOWN THE CANNULA, HE THOUGHT THE SCREW HEAD WAS GOING TO BECOME STUCK AGAIN. SURGEON REMOVED THE CANNULA TO ATTEMPT TO IMPLANT THE SCREW, COULD NOT FIND THE DRILLED HOLE, AND HAD TO MAKE AN INCISION TO REMOVE THE SCREW. SURGERY WAS COMPLETED WITH AN OVERALL DELAY OF APPROXIMATELY 20 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405949 ↗
• MalfunctionJul 12, 2018Break; Detachment of Device or Device Component

  CUSTOMER REPORTS THAT 1 CM GUIDEWIRE INCL HEAD BROKE OFF IN THE STEM OF THE HUMERUS (DURING UPREAMING). A PART REMAINED IN THE HUMERUS.

  Patient problems: Foreign Body In Patient

  MAUDE report 7682840 ↗
• MalfunctionOct 27, 2016Device Contamination with Chemical or Other Material

  IN IN-COMING INSPECTION AT DISTRIBUTION, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) IN BLISTER. THIS EVENT WAS FOUND ON 1 OF 20 UNITS, LOT#K09888B RECEIVED ON OUR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6062287 ↗
• MalfunctionSep 29, 2015Shelf Life Exceeded; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, AN OUT OF DATE GUIDEWIRE WAS MISTAKENLY USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5112043 ↗