Arthrex® AR-9094AR-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867410732), received between May 19, 2025 and May 19, 2025 — classified as 1 injury.

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

• InjuryMay 19, 2025Break; Break

  ON 04/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-9094-09L TELESCOPING LAG SCREW WAS INSERTED FOR A LEFT HIP DURING A INTERTROCHANTERIC HIP FRACTURE ON (B)(6) 2025. DURING THE INSERTION, THE SURGEON TURNED THE SCREW, CAUSING ITS THREADS TO SHEAR OFF. AS A RESULT, ADJUSTMENTS HAD TO BE MADE TO THE AR-9094AR-080 ANTI-ROTATION SCREW, AND THE PROCEDURE REQUIRED TRANSITIONING TO A REGULAR LAG SCREW. THIS ISSUE EXTENDED THE OPERATION BY APPROXIMATELY ONE HOUR. THE SURGEON MADE EFFORTS TO RETRIEVE AS MANY OF THE BROKEN METAL THREADS AS POSSIBLE; HOWEVER, SOME REMAINED VISIBLE ON THE POSTOPERATIVE X-RAY. ADDITIONALLY, THE ANTI-ROTATION SCREW REQUIRED FURTHER ADJUSTMENT AND DOWNSIZING DUE TO THE ISSUE. DESPITE THE SURGEON'S ATTEMPTS TO REMOVE THE REMAINING FRAGMENTS BEFORE CLOSURE, NOT ALL COULD BE RETRIEVED. THIS WAS DISCOVERED DURING USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22047652 ↗