Arthrex® AR-13100-17.5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867007611), received between Oct 21, 2016 and Oct 21, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2016Device Operates Differently Than Expected

  LEGAL: IT WAS REPORTED THAT PATIENT WAS DIAGNOSED WITH A RIGHT DISTAL FEMORAL VALGUS AND UNDERWENT AN OPENING WEDGE OSTEOTOMY ON (B)(6) 2004. OPERATIVE REPORT NOTED THAT AS THE SURGEON APPROACHED THE MEDIAL SIDE, THE DISTAL ASPECT OF THE OSTEOTOMY WAS FOUND TO HAVE FRACTURED TO THE MEDIAL CORTEX. AN ARTHREX AR-13100-17.5, FEMORAL OPENING WEDGE OSTEOTOMY 17.5 MM PLATE WAS IMPLANTED TO REPAIR THE OSTEOTOMY. THREE ARTHREX AR-13303-2.4, OSTEOTOMY GUIDE PINS 2.4MM WERE ALSO USED. IN ADDITION, NUMEROUS SCREWS FROM ANOTHER MANUFACTURER WERE USED DURING THE (B)(6) 2004 PROCEDURE. ON (B)(6) 2005 PATIENT UNDERWENT A REVISION SURGERY BY ANOTHER SURGEON DUE TO SIGNIFICANT RIGHT DISTAL FEMUR NON-UNION. OPERATIVE REPORT NOTES THIS WAS CONFIRMED BY CT. DURING THE REVISION SURGERY THE ARTHREX PLATE FROM THE (B)(6) 2004 PROCEDURE AND ALL SCREWS WERE EXPLANTED. THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCT.

  Patient problems: Congenital Defect/Deformity

  MAUDE report 6048440 ↗