Arthrex® AR-8963AR-16Recalls & reported problems
Arthrex, Inc. · ANTEROLAT DIST TIB PLT, SS, RIGHT, 16H · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867223288), received between Jun 14, 2018 and Jan 5, 2026 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Failure of Implant1
- 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.
InjuryJan 5, 2026Break
IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A POST OPERATIVE PLATE BREAKAGE. NO FURTHER INFORMATION RECEIVED. UPDATE ON 19-DEC-2025: FURTHER INFORMATION WAS PROVIDED THAT THE PLATE BROKE 3 MONTHS AFTER THE INITIAL SURGERY AND THE REVISION WAS PERFORMED ON (B)(6) 2025.
Patient problems: Failure of Implant
MAUDE report 23957969 ↗InjuryJun 14, 2018Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY WHERE AN ARTHREX PLATE WAS IMPLANTED INTO THE PATIENT'S ANKLE. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED TO REMOVE THE PLATE. FOLLOW-UP INVESTIGATION: THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2018. THE REP IS UNSURE HOW THE PLATE BROKE AND IF THE PATIENT WAS EXPERIENCING ANY PAIN OR DISCOMFORT PRIOR TO THE REVISION. THE SAME SURGEON PERFORMED BOTH, THE ORIGINAL SURGERY AND THE REVISION. NONE OF THE EXPLANTED HARDWARE IS AVAILABLE FOR RETURN. THE FOLLOWING DEVICES WERE ALSO EXPLANTED: AR-8827L-30 / LOT: 1530123, AR-8827L-32 / LOT: 10015375, AR-8827L-34 / LOT: 186497, AR-8835-20 / LOT: 10143062, AR-8835-22 / LOT: G52513, AR-8835-24 / LOT: 10050103, AR-8835-24 / LOT: W47426, AR-8835-26 / LOT: W47430.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7600185 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page