Arthrex® AR-8933-16PTRecalls & reported problems
Arthrex, Inc. · LO-PRO SCRW,TI,3X 16MMCANN,PT THD · 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 00888867049529), received between Aug 1, 2016 and Aug 1, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2016Patient-Device Incompatibility
IT WAS REPORTED BY PATIENT THAT SHE HAD SURGERY ON HER RIGHT FOOT (B)(6) 2012 FOR DECOMPRESSION, OSTEOTOMY AND BUNIONECTOMY OF HER GREAT TOE AND LITTLE TOE. DURING THE PROCEDURE THE FOLLOWING PARTS WERE IMPLANTED: AR-8930-10 (LOT 13578A) AND AR-8933-16PT (LOT 16E4Y). PATIENT REPORTS THAT SHE HAS BEEN HAVING REACTION SYMPTOMS SINCE SURGERY WHICH PHYSICIAN HAS BEEN TREATING OVER THE PAST SEVERAL YEARS. PATIENT REPORTS BLISTERS IN THE GREAT TOE AREA. PATIENT HAS A KNOWN NICKEL ALLERGY.
Patient problems: Reaction
MAUDE report 5837691 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, 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 18, 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