NA 03.019.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982069528), received between Apr 1, 2019 and Jul 3, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON JUNE 7, 2024 THE TROCAR IS BENT AND NEEDS TO BE REPLACED. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.8MM TROCAR FOR 03.019.014 THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19668350 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TOP OF THE MULTILOC TROCAR WAS REPORTED TO HAVE BROKEN OFF. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.8MM TROCAR FOR 03.019.014 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18874355 ↗
• MalfunctionMar 23, 2023Break; Break

  IT WAS REPORTED THAT ON MARCH 7, 2023, WHILE SETTING UP THE SCRUB TECH BEFORE CASE, SCRUB TECH PULLED THE TROCAR OUT OF TRAY AND THE TOP PIECE CAME OFF. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.8MM TROCAR FOR 03.019.014. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600842 ↗
• MalfunctionMar 3, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TROCAR FROM MULTILOC HUMERAL NAIL CAME OUT OF THE WASH IN STERILE PROCESSING DEPARTMENT WITH HEAD BROKEN OFF OF THE TROCAR. NO PATIENTS INVOLVEMENT IS THERE . THIS COMPLAINT INVOLVES ONE (1) DEVICE 3.8MM TROCAR FOR 03.019.014. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658795 ↗
• MalfunctionJun 28, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGICAL PROCEDURE TROCAR 3.8 WAS USED THAT COMES WITH THE SET OF SLEEVES AND DRILL GUIDES OF THE MULTILOC SYSTEM. THE PIECE WAS FOUND WITHOUT HEAD AND WAS CHANGED BY ANOTHER ONE THAT COMES IN THE EQUIPMENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY COMPLICATIONS. CONCOMITANT DEVICES REPORTED: UNKNOWN SLEEVES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN DRILL GUIDES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 3.8MM TROCAR FOR 03.019.014. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080584 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ROUTINE INCOMING INSPECTION OF LOANER SET, IT WAS OBSERVED THAT 3.8MM TROCAR WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 3.8MM TROCAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8469457 ↗