NA 1806-6172Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540510082), received between May 11, 2020 and Oct 16, 2025 — 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. 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.

• MalfunctionOct 16, 2025Fracture; Off-Label Use; Mechanical Jam; Fracture; Off-Label Use; Mechanical Jam

  AS REPORTED: "'DESCRIPTION ACCORDING TO THE OPERATING ROOM: INTRAOPERATIVELY, THE THREAD OF INSERT 1806-6172 BROKE. THE INSERT BECAME STUCK IN THE THREAD AND COULD NO LONGER BE DISCONNECTED.'' UPDATE SEPTEMBER 22, 2025. HOW WAS THE EVENT RESOLVED? OTHER SURGICAL TRAYS AND INSTRUMENTS WERE OPENED. WAS THE EXPLANTED IMPLANT A STRYKER/WRIGHT MEDICAL OR FROM COMPETITION? THE PRODUCT WAS ONE FROM THE COMPETITION. IF STRYKER/WRIGHT MEDICAL, WHY DID THE SURGEON DECIDE TO EXPLANT THE DEVICE? PATIENT REQUEST. IF THE DEVICE WAS BROKEN OR DAMAGED: WAS THERE HARD/DENSE BONE? IT WAS HARD DENSE BONE. WAS THERE ANY DEBRIS REPORTED? WERE THEY ALL REMOVED FROM THE SURGICAL FIELD/PATIENT? ALL DEBRIS COULD BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316684 ↗
• MalfunctionApr 5, 2023Break; Fracture; Break; Fracture

  AS REPORTED BY THE SALES REP, "SURGEON ENCOUNTERED DIFFICULTIES IN THE REMOVAL OF A T2 TIBIA NAIL. IT PROVED IMPOSSIBLE TO REMOVE THE OBTURATOR PLUG AND, BY EXTENSION, THE NAIL DESPITE THE USE OF STRYKER EXTRACTION KITS. A LEFT-HANDED SCREWDRIVER, REFERENCE 1806-6172, BROKE OFF IN THE PLUG."

  Patient problems: Insufficient Information

  MAUDE report 16685981 ↗
• MalfunctionFeb 7, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "ONE ITEM BROKE DURING THE SURGERY, MALE EXTRACTOR 4MM. THE ITEM SNAPPED DURING USE, REMOVING A SCREW. THE PROCEDURE WAS DELAYED BY 40 MIN." IT IS UNCLEAR IF ANY DEBRIS WAS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311921 ↗
• MalfunctionMar 9, 2021Fracture; Fracture

  "THE CUSTOMER REPORTED THAT WHILST ATTEMPTING TO EXTRACT A CANNULATED HIP SCREW OUT OF A PATIENT, A PIECE OF THE INSTRUMENT SHEARED OFF INTO THE CANNULATED SCREW."

  Patient problems: Insufficient Information

  MAUDE report 11448980 ↗
• MalfunctionMay 11, 2020Fracture; Fracture

  IT WAS REPORTED, TIP OF EXTRACTION TOOL BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10044642 ↗