NA XFO012002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252265320), received between Aug 30, 2022 and Oct 31, 2023 — 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.

• MalfunctionOct 31, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED BY THE CUSTOMER THAT THE DRILL BIT FROM THE EZ CLIP SET BROKE OFF INTO THE BONE OF THE PATIENT. DRILL BIT WAS NOT REMOVED FROM THE PATIENTS LEFT FOOT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18044222 ↗
• MalfunctionAug 30, 2022Break; Fracture; Break; Fracture

  PROCEDURE PERFORMED: ACHILLES TENDON LENGTHENING LEFT FOOT. TRIPLE ARTHRODESIS WITH INTERNAL FIXATION LEFT FOOT. THE TIP OF A 2MM DRILL BIT INADVERTENTLY BROKE OFF AND "APPEARED TO BE IMBEDDED IN THE AREA OF THE SINUS TARSI" OF THE LEFT FOOT DURING A PART OF THE PROCEDURE WHERE "AGGRESSIVE DRILLING OF THE BONE" TO STIMULATE CARTILAGE REPAIR WAS PERFORMED. SURGEON ATTEMPTED TO REMOVE IT, HOWEVER "DECIDED TO LEAVE IT IN PLACE DUE TO ITS'S BENIGN POSITION". SURGEON INDICATED HE WOULD DISCLOSE THIS TO THE PATIENT. THERE WAS NO MALFUNCTION OF DRILL. FDA SAFETY REPORT ID # MW5111089.

  Patient problems: Foreign Body In Patient

  MAUDE report 15325215 ↗