AESCULAP FH413Recalls & reported problems
Aesculap AG · GIGLI WIRE SAW IN 6 PARTS 300MM LONG · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653165971), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2021Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FH413 - GIGLI WIRE SAW IN 6 PARTS 300MM LONG. ACCORDING TO THE COMPLAINT DESCRIPTION, A JIGSAW WAS USED TO REMOVE THE ACETABULUM DURING SALTER SURGERY. AFTER SURGERY, MRI IMAGING WAS PERFORMED, AND IT WAS CONFIRMED THAT HALATION (ARTIFACT) APPEARED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12820515 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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