Arthrex® AR-18700-34Recalls & reported problems
Arthrex, Inc. · BB-Tak, Small · Class 1 · Implant
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 00888867312784), received between Nov 14, 2022 and Nov 14, 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
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-18700-34 BB-TAK, AND A AR-18700-89 DRILL BIT BROKE. THIS OCCURRED ON (B)(6) 2022 DURING A CUNIEFORM FX WHEN THE SURGEON WAS USING A 1.6 CAGE PLATE OUT OF THE MINIFRAG FOR A MEDIAL CUNIEFORM FX. SHE WAS DRILLING WITH THE 1.2 DRILL BIT WITH THE VARIABLE ANGLE GUIDE AND THE DRILL BIT BROKE OFF INTO THE PATIENT. SHE WAS ABLE TO RETRIEVE THE FRAGMENT. AFTER THAT THEY SWITCHED TO THE SHORT 1.2 DRILL BIT AND STILL USED THE VARIABLE ANGLE GUIDE. ALL WAS GOING WELL UNTIL DRILLING FOR THE VERY LAST SCREW. THE 1.2 SHORT DRILL BROKE ALSO. ALL FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 15794062 ↗
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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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