NA 332.173Recalls & reported problems
Synthes GmbH · CANNULATED CHISEL FOR INFANT OSTEOTOMY PLATES · Class 1
Data updated Oct 13, 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 10886982192646), received between Sep 11, 2020 and Sep 11, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2020Material Deformation; Material Deformation
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2020, THE SURGEON ATTEMPTED TO PUT THE CUTTING GUIDE ON THE CHISEL VIA THE BLUNT END AND IT WOULD NOT GO ON. UPON INSPECTION EACH OF THE THREE CHISELS WERE FOUND TO HAVE BURRED ENDS AS A RESULT OF HAMMER BLOWS TO INSERT THE CHISEL INTO BONE. THE SURGEON DECIDED TO NOT USE THE CUTTING GUIDE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: UNKNOWN HAMMER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN), UNKNOWN CUTTING GUIDE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10521829 ↗
Other CHISEL, SURGICAL, MANUAL devices
- SIGMA 2024-85-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL63 reports
- NA 2421-01-000Depuy (Ireland) · CHISEL, SURGICAL, MANUAL36 reports
- NA 399.56Synthes GmbH · CHISEL, SURGICAL, MANUAL11 reports
- NA 399.55Synthes GmbH · CHISEL, SURGICAL, MANUAL10 reports
- T.L.I.F. 274279000Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL7 reports
- NA 332.121Synthes GmbH · CHISEL, SURGICAL, MANUAL5 reports
- INSTRUMENT 6541-4-709Howmedica Osteonics Corp. · CHISEL, SURGICAL, MANUAL4 reports
- NA 202953Depuy Spine, LLC · CHISEL, SURGICAL, MANUAL4 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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