NA 219966Recalls & reported problems
Medos International Sàrl · GRAFT SIZER Percent Accuracy = Plus or Minus 3 Percent · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705007080), received between Oct 2, 2020 and May 20, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Crack1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2024Break; Use of Device Problem; Break; Use of Device Problem
IT WAS REPORTED BY THE SALES REP THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024 THE GRAFT SIZER WAS DROPPED A SIZING BLOCK ON THE FLOOR AND IT BROKE IN HALF. ANOTHER LIKE DEVICE USED 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 19349623 ↗MalfunctionSep 27, 2021Crack; Crack
IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE GRAFT PREP SYS GRAFTSIZER DEVICE WAS CRACKED. ANOTHER LIKE DEVICE USED 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 12533954 ↗MalfunctionOct 2, 2020Break; Break
IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING THE CLEANING PROCESS AFTER AN UNKNOWN PROCEDURE IT WAS NOTICED THAT THE GRAFT SIZER WAS BROKEN. NO PATIENT OR PROCEDURE INVOLVED. THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10622596 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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