NA 02.111.001Recalls & reported problems
Synthes GmbH · TREPHINE GUIDE WIRE WITH STOP 3.2MM DIAMETER/1.6MM TIP · Class 1
Data updated Oct 18, 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 10886982031075), received between Sep 16, 2022 and Sep 16, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionSep 16, 2022Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE WIRE SNAPPED DURING THE PROCEDURE, IT SNAPPED AT THE JUNCTION WHERE IT CHANGES FROM 1.6MM TO 3.2MM. THE SNAPPED WIRE WAS REMOVED AND ANOTHER ONE WAS USED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) TREPHINE GUIDE WIRE WITH STOP 3.2MM DIAMETER/1.6MM TIP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15437936 ↗
Other TREPHINE devices
- NA 03.111.030Synthes GmbH · TREPHINE44 reports
- NA 387.661Synthes GmbH · TREPHINE6 reports
- NA 03.111.025Synthes GmbH · TREPHINE5 reports
- NA 03.111.026Synthes GmbH · TREPHINE3 reports
- NA 03.111.031Synthes GmbH · TREPHINE3 reports
- NA 387.660Synthes GmbH · TREPHINE3 reports
- 7mm VersiTomic ISI Biosteon TapT.A.G Medical Products Agricultural Cooperative Association · Trephine2 reports
- NA 387.662Synthes GmbH · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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