NA 03.111.031Recalls & reported problems
Synthes GmbH · BONE HARVESTING TREPHINE STYLET · 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 10886982072290), received between Jul 8, 2019 and May 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent2
- Device-Device Incompatibility1
- Difficult to Insert1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT (B)(6) 2025, THE DISTRACTOR WAS FOUND NOT TO BE WORKING POST-OPERATIVELY IN THE STERILE PROCESSING DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22064115 ↗MalfunctionSep 10, 2019Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED ON AN UNKNOWN DATE THAT BONE HARVESTING TREPHINE STYLET WAS FOUND BENT WHEN PUTTING UP SET. THERE IS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (1) PATIENT. THIS REPORT IS 1 OF 1 FOR...
Patient problems: No Patient Involvement
MAUDE report 8983282 ↗MalfunctionJul 8, 2019Material Deformation; Difficult to Insert; Material Deformation; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BONE HARVESTING TREPHINE STYLET WAS USED TO REMOVE AN AUTOGRAFT. THE STYLET BENT AND WOULD NOT FULLY INSERT INTO THE SHAFT OF THE TREPHINE ATTACHMENT. IT ENDED UP USING A K-WIRE TO GET IT OUT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SHAFT FOR TREPHINE ATTACHMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8769633 ↗
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 387.662Synthes GmbH · TREPHINE2 reports
- 7mm VersiTomic ISI Biosteon TapT.A.G Medical Products Agricultural Cooperative Association · Trephine2 reports
- NOVOCART FR660SUAesculap AG · TREPHINE1 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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