Arthrex® AR-13100T-17.5Recalls & reported problems
Arthrex, Inc. · PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867007703), received between Apr 4, 2022 and May 23, 2024 — classified as 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Break; Break
IT WAS REPORTED THAT DURING A LOW FEMORAL OSTEOTOMY THAT A PART OF THE PLATE BROKE OFF WHILE THE SURGEON WAS TRYING TO BEN IT WITH THE PLATE BENDER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19380812 ↗MalfunctionApr 4, 2022Break
IT WAS REPORTED THAT THE DEVICE BROKE AFTER IMPLANTATION. THE DEVICE WAS IMPLANTED ON THE (B)(6) 2021 AND ON THE (B)(6) 2022 THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 13995012 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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