NA XFO082001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613252265511), received between Jan 17, 2019 and Jan 18, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED THAT DRILL BIT SNAPPED. UPDATE: X-RAY TO LOCATE DRILL TIP. SURGEON BELIEVES THAT DRILL BIT MAY HAVE CONTACTED AN IMPLANT IN PLACE FROM PREVIOUS SURGERY. THE BROKEN DRILL BIT WAS LEFT IN SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 13277170 ↗
• MalfunctionSep 23, 2020Fracture; Fracture

  AS REPORTED: "USING MMI ANCHORAGE MTP CP PLATE, WHILE USING THE DISTAL LOCKING GUIDE A 2.0MM DRILL BIT TIP BROKE OFF IN THE PATIENT AND WE WERE UNABLE TO RECOVER IT. ALONG WITH THE DRILL BIT WHILE SCREWING IN THE LAST 3.5MM LOCKING SCREW THE T8 SCREWDRIVER TIP BROKE OFF IN THE SCREW HEAD UNABLE TO GET LOOSE AND OUT OF THE SCREW HEAD. BOTH DRILL BIT AND SCREWDRIVER HEAD STUCK IN THE SCREW WERE LEFT IN THE PATIENT AND SURGICAL SITE CLOSED." NO DELAY¿S OR MAJOR DISTRACTION TO THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 10573206 ↗
• MalfunctionApr 18, 2019Break; Fracture; Detachment of Device or Device Component; Fracture

  DURING FOOT SURGERY USING THE ANCHORAGE 1, LISFRANC PLATE. THE SURGEON HAD DRILLED 4 HOLES, ON THE FIFTH THE 2.0MM DRILL BIT BROKE IN THE BONE. THE DRILL BIT WAS DEEP IN THE BONE SO IT WAS DECLARED SAFE TO LEAVE IN THE BONE BY THE SURGEON. SURGICAL DELAY WAS MINIMAL AS THE SURGEON KNEW THE DRILL COULD NOT BE REMOVED.

  Patient problems: Alteration In Body Temperature

  MAUDE report 8527701 ↗
• MalfunctionJan 17, 2019Break; Fracture; Material Fragmentation; Fracture

  PRIMARY LEFT LAPIDUS BUNIONECTOMY. IT WAS REPORTED THAT TWO 2.0 DRILL BITS BROKE WHEN THEY HIT PREVIOUSLY IMPLANTED SCREWS. DURING BONE FENESTRATION, A 1.4 DRILL BIT BROKE IN PATIENT'S BONE (NO CONTACT WITH ANY DEVICES). PATIENT'S BONE QUALITY WAS NORMAL. A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS CAUSED DUE TO THE NEED TO REMOVE THE BROKEN PORTION OF THE BITS, PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257059 ↗
• MalfunctionJan 17, 2019Break; Fracture; Fracture

  PRIMARY LEFT LAPIDUS BUNIONECTOMY. IT WAS REPORTED THAT TWO 2.0 DRILL BITS BROKE WHEN THEY HIT PREVIOUSLY IMPLANTED SCREWS. DURING BONE FENESTRATION, A 1.4 DRILL BIT BROKE IN PATIENT'S BONE (NO CONTACT WITH ANY DEVICES). PATIENT'S BONE QUALITY WAS NORMAL. A SURGICAL DELAY OF LESS THAN 10 MINUTES WAS CAUSED DUE TO THE NEED TO REMOVE THE BROKEN PORTION OF THE BITS, PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257055 ↗