7mm VersiTomic ISI Biosteon TapRecalls & reported problems
T.A.G Medical Products Agricultural Cooperative Association · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10810190016258), received between Jan 11, 2018 and Jan 21, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2018Break; Break
AS WE WERE PLACING THE TITANIUM SCREW INTO THE FEMUR AND THE PHYSICIAN TIGHTENED ONE LAST TIME AND THE TRINKLE BROKE AT THE PROXIMAL END JUST BEFORE THE HEX DRIVER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7208773 ↗MalfunctionJan 11, 2018Break; Break
FLEXIBLE 7MM TAP BROKE OFF INTO PATIENT AS SURGEON STARTED TO UNSCREW IT AFTER TAPPING THE 28MM LINE.
Patient problems: Foreign Body In Patient
MAUDE report 7182018 ↗
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
- NA 387.662Synthes GmbH · TREPHINE2 reports
- ACE 04948001Ace Surgical Supply CO., Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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