Arthrex® AR-8942W-2006Recalls & reported problems
Arthrex, Inc. · BioSync Evans Wedge, 20 X 20 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867202801), received between Dec 22, 2021 and Dec 22, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Material Disintegration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2021Material Disintegration; Device Dislodged or Dislocated
ON (B)(6) 2021, IT WAS REPORTED BY A LEGAL REPRESENTATIVE VIA EMAIL THAT A PATIENT HAD A RIGHT ANKLE RECONSTRUCTION SURGERY WHICH OCCURRED IN (B)(6) ON (B)(6) 2017. DURING SURGERY, AN ARTHREX EVANS BIOSYNC WEDGE WAS PLACED INSIDE THE ANKLE; HOWEVER, THE EXACT MATERIAL AND BATCH NUMBER ARE UNKNOWN AT THIS TIME. THE SURGERY WAS WITHOUT COMPLICATION AND PATIENT HAD A NORMAL COURSE OF TREATMENT AND RECOVERY POST-OPERATIVELY. IN (B)(6) 2020, PATIENT BEGAN TO EXPERIENCE PERSISTENT PAIN TO HER RIGHT ANKLE AND UNDER WENT A REVISION SURGERY ON (B)(6) 2021 TO REMOVE THE HARDWARE. DURING THE PROCEDURE, SURGEON FOUND MULTIPLE METAL FRAGMENTS EMBEDDED IN THE PATIENT'S TENDON. FURTHER, SURGEON ALSO FOUND THAT THE ANTERIOR PROCESS WAS AVASCULAR, DISINTEGRATING, AND THAT THERE WAS SUBSIDENCE OF THE ARTHREX METALLIC WEDGE. ADDITIONAL INFORMATION RECEIVED 12/2/2021: DEVICE PART NUMBER IS AR-8942W-2006 BIOSYNC EVANS WEDGE FROM BATCH NUMBER 4211.
Patient problems: Pain
MAUDE report 13060625 ↗
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-1806Arthrex, 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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