NA 219961Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705007035), received between Sep 23, 2019 and Aug 7, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2023Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY SALES REP VIA EMAIL THAT DURING ANTERIOR CRUCIATE LIGAMENT REPAIR GRAFT PREP BOARD AND SLIDER UNIT DID NOT SLIDE ONTO THE TRACK WHILE IN USE TOGETHER. ACCORDING TO THE REPORT, BOTH SLIDER UNITS FROM BOTH ENDS WERE TRIED. IT WAS FURTHER REPORTED THAT THEY USED THE GRAFT GRASPERS IN THE STATIONARY HOLES ON THE BLUE FRAME OF THE BOARD TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471339 ↗
• MalfunctionOct 31, 2022Mechanical Jam; Illegible Information; Mechanical Jam; Illegible Information

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SLIDER UNITS ON THE GRAFT PREP BOARD DEVICE WERE GETTING STUCK AND NOT SLIDING SMOOTHLY. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700811 ↗
• MalfunctionSep 23, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED VIA EMAIL BY THE SALES REP THAT DURING AN ACL PROCEDURE THAT THERE WERE MULTIPLE ISSUES WITH THE CUSTOMER'S GRAFT PREP SYSTEM. THE DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES, BUT A DELAY OF 15-20 MINUTES. THE METAL BAR ON THE GRAFT PREP BOARD (PRODUCT CODE 219961) WILL NO LONGER HOLD ONTO THE SLIDER UNIT THAT STRETCHES OUT THE GRAFT TO PREP. THE NUMBERS ON THE GRAFT CUTTING BOARD (219968) ARE WORN MAKING IT HARD FOR THE PERSON PREPPING THE GRAFT TO SEE THE DIMENSIONS. THE SLIDER UNITS (219962) ARE NOT HOLDING THE GRAFT. THE GRAFT PREP TRAY (215810) HAS CRACKS IN IT, AND SOME SLOTS ARE BEING HELD TOGETHER BY A PIECE OF TAPE. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9104402 ↗