NA 387.663Recalls & reported problems
Synthes GmbH · TREPHINE ATTACHMENT 14.0MM DIAMETER · Class 1
Data updated Oct 16, 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 10886982197733), received between Oct 28, 2019 and Oct 28, 2019 — 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 16, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionOct 28, 2019Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TEETH OF A TREPHINE-ATTACHMENT Ø14 F/HOLDER BROKE OFF INTO PATIENT DURING PROCEDURE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9244467 ↗
Other TREPHINE devices
- NA 03.111.030Synthes GmbH · TREPHINE44 reports
- NA 387.661Synthes GmbH · TREPHINE6 reports
- NA 03.111.025Synthes GmbH · TREPHINE5 reports
- NA 387.660Synthes GmbH · TREPHINE3 reports
- NA 03.111.026Synthes GmbH · TREPHINE3 reports
- NA 03.111.031Synthes GmbH · TREPHINE3 reports
- NA 387.662Synthes GmbH · TREPHINE2 reports
- 7mm VersiTomic ISI Biosteon TapT.A.G Medical Products Agricultural Cooperative Association · Trephine2 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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page