NA 399.37Recalls & reported problems
Synthes GmbH · PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE · 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 10886982202758), received between Sep 18, 2019 and Feb 1, 2022 — 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.
Most reported problems
Device problems
- Break2
- Crack1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2022Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE HANDLE OF THE ELEVATOR WAS CHIPPED AT THE HILT. IT WAS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13416832 ↗MalfunctionOct 15, 2019Break; Break
VETERINARY COMPLAINT: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2019, THE PERIOSTEAL ELEVATOR STRAIGHT BLADE SNAPPED IN TWO, ALMOST IN THE MIDLINE, AT THE HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY. PATIENT WAS FINE. THIS REPORT IS FOR A PERIOSTEAL ELEVATOR. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9191798 ↗MalfunctionSep 18, 2019Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PERIOSTEAL ELEVATOR 14 MM STRAIGHT BLADE-ROUND EDGE WAS IN NEED OF REPAIR. THE BLADE HAS SEPARATED FROM THE HANDLE. THE ISSUE WAS DISCOVERED UPON INSPECTION IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) PERIOSTEAL ELEVATOR 14 MM STRAIGHT BLADE-ROUND EDGE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9082456 ↗
Other ELEVATOR devices
- NA 399.36Synthes GmbH · ELEVATOR15 reports
- NA 399.48Synthes GmbH · ELEVATOR15 reports
- NA 399.40Synthes GmbH · ELEVATOR9 reports
- NA 399.481Synthes GmbH · ELEVATOR8 reports
- NA 03.133.202Synthes GmbH · ELEVATOR3 reports
- Innomed, Inc. 3450Innomed, Inc. · Elevator2 reports
- NA 389.56Synthes GmbH · ELEVATOR2 reports
- NA 398.409Synthes GmbH · ELEVATOR1 report
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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