ENNOVATE SZ277RRecalls & reported problems
Aesculap AG · ENNOVATE Rod Persuader, stainless steel, non-sterile, reusable · Class 1
All models of ENNOVATE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964700927), received between Jan 10, 2022 and Jan 10, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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
- Device Damaged by Another Device1
- Difficult to Open or Close1
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.
InjuryJan 10, 2022Device Damaged by Another Device; Difficult to Open or Close; Device Damaged by Another Device; Difficult to Open or Close
IT WAS REPORTED TO AESCULAP AG THAT AN ENNOVATE ROD PERSUADER (PART # SZ277R) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE INSTRUMENT WAS NOT ABLE TO BE OPENED AND IT JAMMED WITH THE SCREW HEAD. THE COMPLAINT DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13213657 ↗
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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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