NA 03.605.006Recalls & reported problems
Synthes GmbH · BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4.5MM 430MM · Class 1
Data updated Oct 18, 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 10705034712383), received between Sep 9, 2021 and Apr 28, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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 18, 2026.
Most reported problems
Device problems
- Material Integrity Problem2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE INSTRUMENT BROKE. THIS COMPLAINT INVOLVES ONE (1) DEVICES BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14238940 ↗MalfunctionApr 5, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON (B)(6) 2022, DURING A PROCEDURE, THE TIP OF THE CURETTE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT DELAY. THIS REPORT IS FOR ONE (1) BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014311 ↗MalfunctionSep 9, 2021Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PITUITARY RONGEUR STRAIGHT, DUAL-SIDED RASP BAYONETED, DEG ANGLED RASP-BAYONETED, TWO (2) BONE CURETTE, BOX CURETTE, OSTEOTOME STRAIGHT, TWO (2) BOX CURETTE, RINGCURETTE AND CONCORDE BONE FUNNEL WERE BROKEN. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE IS PATIENT NOR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) BONE CURETTE-ANGLED/OVAL HEAD 3.5MM X 4. THIS IS REPORT 5 OF 9 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12450187 ↗
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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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