Arthrex® AR-8930-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867049161), received between Jan 13, 2020 and Dec 26, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024 , IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-8930-11,ARTHREX QUICKFIX¿ SCREW, TI, 2 MM X 11 MM, THE SCREWS DID NOT TWIST OFF AFTER INSERTION. THIS WAS DETECTED DURING USE IN A WEILS OSTEOTOMY PROCEDURE ON (B)(6) 2024 . THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS ANOTHER IMPLANT FROM ANOTHER COMPANY WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 21018589 ↗
• MalfunctionJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA E-MAIL THAT AN AR-8930-11 ARTHREX QUICKFIX¿ SCREW PULLED OUT. THIS OCCURRED ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18610191 ↗
• InjuryJan 13, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS PROVIDED THE FOLLOWING INFORMATION: PATIENT HAD UNDERGONE A LEFT FOOT OSTEOTOMY METATARSAL/LEFT WEIL PLANTAR PLATE REPAIR ON (B)(6) 2017. DURING THE PROCEDURE, AN ARTHREX ACP INJECTION SYSTEM (ACP KIT SERIES II, ABS-10012, LOT 616565204, QTY 2) WAS UTILIZED AND 2 ARTHREX QUICK FIX SCREWS WERE IMPLANTED (AR-8930-11, LOT 10111019). THE FOLLOWING ARTHREX PRODUCTS WERE ALSO USE: AR-13930DS (LOT 703771055) MENISCAL VIPER REPAIR KIT AND AR-8690DS (LOT 10091584, QTY 2) IMPLANT SYSTEM, CPR MINI SCORPION DX. AFTER THE LOCAL ANESTHETIC WORE OFF HIS LEFT FOOT FELT LIKE IT WAS ASLEEP AND THE FEELING RADIATED TO JUST ABOVE THE ANKLE BONE. FEELING HAS NOT GONE AWAY SINCE THE SURGERY. CONDITION DOES NOT IMPACT ANY ACTIVITY, EXCEPT IT FEELS STRANGE, OFTEN A DEAD FEELING AND COLD. ONLY EXCEPTION TO FUNCTIONALITY IS PATIENT'S BALANCE WHILE STANDING ON HIS LEFT FOOT ONLY IS SLIGHTLY WORSE THAN THEN STANDING ON HIS RIGHT FOOT. PATIENT HAD REACHED OUT TO THE SURGEON IN EARLY 2019 BUT CHOSE TO FOLLOW UP WITH HIS LOCAL PHYSICIAN WHO REFERRED HIM FOR REVIEW BY A NEUROLOGIST. EMG EXAM WAS CONDUCTED AND MRI'S WERE PERFORMED ON THE LEFT KNEE AND ANKLE. PATIENT RECAP OF TESTING RESULTS: EMG SH

  Patient problems: Neuropathy

  MAUDE report 9580156 ↗