NA 351.92Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982194053), received between Mar 10, 2017 and Nov 22, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionNov 22, 2022Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THESE ARE BROKEN OR UNUSABLE PRODUCTS. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCE. THIS REPORT IS FOR ONE (1)6.0MM HAND REAMER 450MM. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15849240 ↗
• MalfunctionOct 1, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, THE EXTRACTION SCREW, HAND REAMER, AND SCREWDRIVER DID NOT WORK AS INTENDED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) HAND-REAMER F/MEDULL-CANAL Ø6. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564187 ↗
• MalfunctionNov 30, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, IT WAS NOTICED THAT A 6MM HAND HELD REAMER HAD A BROKEN TIP. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.0MM HAND REAMER 450MM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920064 ↗
• MalfunctionOct 16, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, WHILE PUTTING THE SETS BACK TOGETHER AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE HANDLES OF THE TWO (2) HAND HELD REAMERS WERE BROKEN OFF AND NO LONGER USABLE. THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) HAND-REAMER F/MEDULL-CANAL Ø6. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197848 ↗
• MalfunctionMar 10, 2017Break; Break

  IT WAS REPORTED THAT DURING AN INVENTORY AUDIT BY THE SALES CONSULTANT, SIX INSTRUMENTS WERE FOUND TO BE BROKEN OR MISSING COMPONENTS AT THE ATLANTA METRO OFFICE. THESE ARE REPORTEDLY DEVICES THAT WERE TURNED INTO THE METRO OFFICE FROM FORMER CONSULTANTS WHO HAVE LEFT THE COMPANY OR TRANSFERRED TO ANOTHER POSITION. ALL DEVICES ARE FIELD INVENTORY. THERE IS NO REPORT OF ANY PATIENT OR PROCEDURE INVOLVEMENT. THERE ARE SIX DEVICES INVOLVED IN THIS COMPLAINT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6396664 ↗