Arthrex® AR-13430-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012905), received between Jul 14, 2017 and Jul 14, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Bent” (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

Recent adverse event reports

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

• InjuryJul 14, 2017Bent

  IT WAS REPORTED, A LOANER SET WAS USED FOR THE PROCEDURE. THE TEETH ON THE JACK ARMS BEGAN TO BEND AS THE OSTEOTOMY SITE WAS JACKED OPEN. EVENTUALLY THE ARMS WOULD NOT STAY IN PLACE DUE TO THE TEETH BENDING. THEY TRIED TO BEND THE TEETH BACK IN ORDER TO USE THE INSTRUMENT AND INSERT THE IMPLANT, HOWEVER IT WOULDN'T STAY IN PLACE. THE MEASUREMENT GUIDE WAS ALSO INACCURATE DUE TO THE BENT TEETH. THE TWO PARTS OF THE OPENING JACK WERE: AR-13430-01, OPENING JACK BACK ARM ((B)(4)) AND AR-13430-02, OPENING JACK FRONT ARM ((B)(4)). THE SURGEON HAD TO CHANGE PLANS AND WENT WITH A CONTOURLOCK PLATE AFTER TRYING SEVERAL OTHER INSTRUMENTS TO HOLD THE OSTEOTOMY OPEN AND EVENTUALLY FRACTURING THE TIBIAL PLATEAU. THE QUALITY OF THE BONE WAS REPORTED TO BE FAIR. CASE: PROXIMAL TIBIAL OSTEOTOMY. PATIENT: MALE. ADDITIONAL INFORMATION RECEIVED 6/27/2017: THE FRACTURED TIBIAL PLATEAU REDUCED ITSELF WHEN PRESSURE WAS RELEASED. THE SURGEON HAS NO PLANS TO DO ANYTHING FURTHER SURGICALLY DUE TO THE INCIDENT. THE CONTOUR LOCK PLATE THAT WAS USED WAS AN ARTHREX DEVICE AR-13730-02 LOT NUMBER 1264409.

  Patient problems: Bone Fracture(s)

  MAUDE report 6713302 ↗