Arthrex® AR-13430-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012912), received between Nov 2, 2020 and Nov 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Incorrect Measurement” (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.

• InjuryNov 2, 2020Incorrect Measurement; Material Twisted/Bent; Unintended Movement

  THIS IS AN INITIAL REPORT TO RESUBMIT ALL PRIOR INFORMATION THAT WAS SUBMITTED THROUGH ARTHREX SUBMISSION THE INITIAL REPORTS DROPPED FROM THE FDA SYSTEM AND THEREFORE BLOCKED THE FULL PROCESSING OF A FOLLOW UP SUBMISSION. AFTER SEVERAL MONTHS OF INVESTIGATION WITH THE FDA, DUE TO COMPUTER SYSTEM CHANGES AT ARTHREX AS WELL AS THE FDA, THE FDA HAS AGREED THAT ARTHREX SHOULD RESUBMIT A NEW REPORT TO ENCOMPASS THE INITIAL PRIOR 2017 ARTHREX SUBMISSIONS INVOLVED. THIS REPORT IS IN REFERENCE TO: 1220246-2017-00246 (ARTHREX REFERENCE (B)(4)/ LINE 197407). THE FOLLOWING IS THE PREVIOUSLY REPORTED INFORMATION MENTIONED ABOVE: IT WAS ORIGINALLY 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. AR-13430-01 ((B)(4) LINE 197397) AND AR-13430-02, OPENING JACK FRONT ARM, AR-13430-02 ((B)

  Patient problems: Bone Fracture(s)

  MAUDE report 10774452 ↗