Arthrex® AR-1342-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867012561), received between Oct 12, 2023 and Oct 12, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/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 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.

• MalfunctionOct 12, 2023Material Twisted/Bent; Material Twisted/Bent

  ON 9/14/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1342-15 SHOULDER TISSUE ELEVATOR, 15° HAD AN ISSUE. THE INSTRUMENT WAS BENT DURING SURGERY BUT DID NOT BREAK, AND THE SURGERY CONTINUED WITH A NEW INSTRUMENT. THIS OCCURRED DURING USE IN AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 9/18/2023, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: THIS OCCURRED DURING A LABRAL REPAIR AND DEBRIDEMENT PROCEDURE - HWR METAL ANCHORS FROM THE GLENOID. THIS WAS A REVISION SURGERY, BUT NO ARTHREX PRODUCTS WERE BEING REMOVED. THE INITIAL FIRST SURGERY DATE WAS NOT PROVIDED. ANOTHER AR-1342-15 SHOULDER TISSUE ELEVATOR, 15° WITH AN UNKNOWN LOT NUMBER, WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE BONE QUALITY OF THE PATIENT WAS NOT PROVIDED. NO PICTURES WERE TAKEN. THERE WAS NO ADVERSE EFFECT TO THE PATIENT REPORTED AND NO CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17921712 ↗