Arthrex® AR-8942W-1806Recalls & reported problems
Arthrex, Inc. · BioSync Evans Wedge, 18 x 18 x 6.5 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867202764), received between Dec 7, 2020 and Dec 7, 2020 — classified as 1 injury.
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
- Failure of Implant1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2020Break
IT WAS REPORTED THAT A PATIENT HAD AN INITIAL DISTAL EXTREMITY EVANS OSTEOTOMY SURGERY (B)(6) 2019 USING AN AR-8942-1809 (LOT 4266), BIOSYNC EVANS WEDGE 18 X 18 X 6.5. THE PATIENT WAS COMPLAINING ABOUT NEW FOOT PAIN WITH NO REPORT OF ANY TRAUMATIC EVENT. PATIENT WOKE UP ONE MORNING WITH A GOOD DEAL OF PAIN IN THEIR PREVIOUSLY OPERATED ON FOOT. (B)(6) 2020 THE PATIENT UNDERWENT A SECOND SURGERY. AFTER DISSECTION IT WAS NOTICE INSTANTLY THAT THE BIOSYNC EVAN WEDGE WAS BROKEN. IT WAS FRAGMENTED INTO FOUR SEPARATE PIECES, ONLY BEING HELD IN PLACE BY IT'S SCREWS. SURGEON RELAYED TO THE SALES REP THAT HE WAS SHOCKED THAT THIS ISSUE OCCURRED, ADDING THAT HE HAD NEVER SEEN ONE BREAK BEFORE. THE DEVICE WILL NOT BE RETURNED AS THE FACILITY KEPT IT FOR PATHOLOGY. ADDITIONAL INFORMATION OBTAINED 11/17/20: TO REMOVED THE BIOSYNC EVANS WEDGE THE TWO ORIGINAL IMPLANTED SCREWS ALSO HAD TO BE EXPLANTED. THE TWO SCREWS WERE AS FOLLOWS: LOW PROFILE SCREW, 2.4 X 20MM, CORTEX (AR-8724-20, LOT # 193349), LOW PROFILE SCREW, 2.4 X 24MM, CORTEX (AR-8724-24, LOT #199124). THE REVISION PROCEDURE WAS COMPLETED WITH A LIFENET ILIAC CREST WEDGE AND THE FOLLOWING ARTHREX PRODUCTS. AR-8952XM, X-PLATE, MEDIUM 3.0M
Patient problems: Failure of Implant; Pain
MAUDE report 10958399 ↗
Other Bone Wedge devices
- Arthrex® AR-8948W-1665Arthrex, Inc. · Bone Wedge2 recalls0 reports
- Arthrex® AR-8948W-2045Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-2065Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-1645Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8948W-2055Arthrex, Inc. · Bone Wedge1 recall0 reports
- Arthrex® AR-8942W-2006Arthrex, Inc. · Bone Wedge1 report
- Arthrex® AR-8948W-2075Arthrex, Inc. · Bone Wedge1 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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