INSTRUMENT 2102-0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327211825), received between Oct 31, 2017 and Dec 23, 2019 — classified as 8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF HOSPITAL INVENTORY IN SPD, THE REAMERS COULD NOT BE RE-ASSEMBLED PROPERLY. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9513198 ↗
• MalfunctionDec 23, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF HOSPITAL INVENTORY IN SPD, THE REAMERS COULD NOT BE RE-ASSEMBLED PROPERLY. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. NO ASSOCIATED PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9513194 ↗
• MalfunctionNov 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  DURING THE OPERATION, IT WAS DISCOVERED THAT THE CUTTER HOLDER (2102-0410) HAD A DEFECT IN THE CONNECTION. NOT SUITABLE FOR T- SHAPED HANDLES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9315785 ↗
• MalfunctionJun 17, 2019Break; Break

  CUSTOMER INFORMED TO CUSTOMER SERVICE ASSISTANT VIA PHONE THAT REAMER HAND PIECE WAS BROKEN OFF TO INSIDE THE ATTACHMENT. THE EVENT DIDN'T CAUSE ANY HARM FOR THE PATIENT OR PERSONNEL OR ANY SURGICAL DELAY. CUSTOMER TOOK A NEW ITEM FOR REPLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703426 ↗
• MalfunctionOct 9, 2018Break; Fracture; Break; Fracture

  SURGEON WAS REAMING THE ACETABULAR AND BASE OF QUICK RELEASE SHEARED ON REAMER. UPDATE: NO SURGICAL DELAY NOR ANY ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948878 ↗
• MalfunctionOct 4, 2018Degraded; Degraded

  NOTICED THAT THE SPRING WAS WEARING DOWN IN SPD FOR REAMERS HANDLE SHAFT.

  Patient problems: No Patient Involvement

  MAUDE report 7933904 ↗
• MalfunctionSep 26, 2018Break; Fracture; Break; Fracture

  REAMER SHAFT HANDLE BROKE UNDER USAGE. REPLACEMENT HANDLE WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7910385 ↗
• MalfunctionOct 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT THE TRIDENT REAMER HANDLE WILL NOT CLIP DOWN TO ATTACH TO THE REAMERS. THE CASE WAS COMPLETED USING COMPETITOR REAMERS WITH A 5 MINUTE DELAY TO SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6990873 ↗