Arthrex® AR-13380-34Recalls & reported problems
Arthrex, Inc. · SCREW, CORTICAL 4.5 X 34MM · Class 2 · Implant
Data updated Oct 16, 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 00888867011526), received between Oct 25, 2017 and Oct 25, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2017Insufficient Device Problem Information
IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT A DISTAL FEMORAL OSTEOTOMY PROCEDURE WHERE THE FOLLOWING DEVICES WERE IMPLANTED: CORTICAL SCREW, AR-13380-34 (LOT: 10140529, LINE 208645), AR-13110R-01 (LOT: 10129525, LINE 210798), AR-13370-1 (LOT: M16906P016, LINE 210799), AR-13370-2 (LOT: M16914C015, LINE 210800), AR-13280-55 (LOT: 10122391, LINE 210801), AR-13380-44 (LOT: 10124044, LINE 210802) AR-13380-46, (LOT: 10084866, LINE 210803), AR-13380-38 (LOT: 10136981, LINE 210804), AND, AR-13880-36 (LOT: 10136979, LINE 210805) INTO THE PATIENT'S FEMUR. DURING THE PROCEDURE, AN AP X-RAY WAS TAKEN WITH NO INDICATIONS OF ANY ABNORMALITIES. ON (B)(6) 2017, THE PATIENT CAME IN FOR A POST-OP CHECK-UP WHERE A LATERAL X-RAY WAS TAKEN SHOWING A FRACTURE IN THE PATIENT'S FEMUR. THE PATIENT HAS NOT EXPERIENCED ANY PAIN OR DISCOMFORT. THE SURGEON IS GOING TO KEEP THE PATIENT NON-WEIGHT BEARING FOR A FEW MORE WEEKS. PATIENT IS A FEMALE.
Patient problems: Bone Fracture(s)
MAUDE report 6975633 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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