PROFYLE 60-14326Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540246721), received between Jan 28, 2019 and Dec 4, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2023Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED: "PATIENT OPERATED ON 04/10/2023 FOR OSTEOSYNTHESIS OF METACARPUS D3 AND D4. DURING BONE DRILLING IN PREPARATION FOR SCREW INSERTION OF A SCREW, THE ANCILLARY DRILL BIT BROKE OFF FLUSH WITH THE BONE, PREVENTING ANY ATTEMPT TO EXTRACT THE DRILL BIT WITHOUT BEING MORE DELETERIOUS. THE SURGEON DECIDED TO LEAVE THE DRILL BIT IN THE METATARSAL".

  Patient problems: Foreign Body In Patient

  MAUDE report 18263112 ↗
• MalfunctionFeb 17, 2022Break; Fracture; Break; Fracture

  "PER THE CUSTOMER, DRILL BIT BROKE DURING PROCEDURE. PIECE OF DRILL BIT WAS UNABLE TO BE RETRIEVED IN BONE PER SURGEON." PROCEDURE WAS AN ORIF OF FINGER.

  Patient problems: Foreign Body In Patient

  MAUDE report 13553066 ↗
• MalfunctionJan 28, 2019Break

  DOCTOR BROKE DRILL AND SCREW DRIVER BLADES WERE STRIPING SCREW HEADS BECAUSE THEY ARE OLD. NEED REPLACEMENTS BUT SURGERY CENTER HAS POLICY WITH VENDORS WHERE THEY DO NOT PAY FOR DRILLS OR SCREW DRIVER BLADES FOR CONSIGNED INVENTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283528 ↗