NA 215810Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705005345), received between Aug 29, 2023 and Jan 9, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE GRAFT PREP SYS TRAY DEVICE WAS BROKEN (2+ PIECES) : DEVICE FRACTURED. IT WAS INITIALLY REPORTED THAT BEFORE A KNEE SCOPE PROCEDURE THE GRAFT PREP TRAY HAD A HOLE WITH SHARP EDGES THAT MADE IT UNUSABLE AND UNSAFE TO PROCESS. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019848 ↗
• MalfunctionMar 7, 2024Break; Crack; Break; Crack

  IT WAS REPORTED BY THE SALES REP THAT THE GRAFT PREP SYS TRAY *EA DEVICE BOTTOM OF THE TRAY WAS CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN IN 2+ PIECES. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18858059 ↗
• MalfunctionDec 18, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT THE GRAFT PREPARATION SYSTEM TRAY WAS BROKEN. THE DEVICE WAS STOCKED IN THE SHELF OF THEIR WAREHOUSE THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18348371 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED BY SALES REP THAT THE GRAFT PREP STERILIZATION TRAY WAS BROKEN AT THE BOTTOM WHILE STRAIGHTENING UP THE WAREHOUSE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646114 ↗