Arthrex® AR-9944S-0RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867345720), received between Sep 19, 2022 and Jul 8, 2025 — classified as 1 injury, 2 malfunctions.

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 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.

• MalfunctionJul 8, 2025Defective Device; Defective Device

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-9944S-0R, MAXFORCE¿ MTP COMPRESSION PLATE, STD, 0° VALGUS, 0° DORSIFLEX, RIGHT AND AN AR-8933VCL-20, KREULOCK¿ COMPRESSION SCREW, TI, 3 MM X 20 MM, DURING THE INSERTION OF THE 3MM KRUELOCK SCREW, IT FELL THROUGH THE PLATE AND WAS NOT ENGAGING THE LOCKING THREAD. THE SCREW WAS CHECKED TO CONFIRM 3MM FITTING ON T10 SCREWDRIVER. 2MM DRILL WAS USED THROUGH FIXED LOCKING TOWER. THE SURGEON WAS UNABLE TO REMOVE SCREW AND IT REMAINS IN PATIENT. THIS WAS DETECTED DURING USE IN AN UNSPECIFIED PROCEDURE ON (B)(6) 2025. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED THAT THIS WAS DETECTED DURING USE IN A MTPJ FUSION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025 - THE COMPLAINT INITIATOR REPLIED WITH THE BATCH NUMBERS HOWEVER, FOR AR-8933VCL-20, THE COMPLAINT INITIATOR IS UNSURE WHICH WAS THE BATCH NUMBER OF THE DEFECTIVE SCREW AS 2 AR-8933VCL-20 WERE USED BUT THE COMPLAINT INITIATOR COULD NOT IDENTIFY WHICH ONE OF THE TWO SCREWS WAS RELATED TO THE DEFECT COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440846 ↗
• InjuryMay 14, 2024Material Fragmentation; Material Fragmentation

  ON 4/15/2024, IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL/SURGEON VIA PHONE THAT AN UNKNOWN LOCKING SCREW WITH AN UNKNOWN LOT NUMBER HAD AN ISSUE DURING A FIRST MTP FUSION PROCEDURE ON (B)(6) 2024. WHEN THE SURGEON WAS USING THE FIRST MTP FUSION PLATE, A LOCKING SCREW WAS PUT IN AND HAD TO BE REPLACED BECAUSE IT WAS TOO LONG. ANOTHER SHORTER LOCKING SCREW WAS PUT IN, AND A CURLY PIECE OF METAL DEBRIS, LIKE A SHARP WIRE, SMALLER THAN AN EYELASH, SEPARATED FROM THE SCREW AND BROKE OFF INSIDE THE PATIENT, WHICH WAS INITIALLY NOT NOTICED. WHEN WASHING OUT THE WOUND, THE METAL PIECE STABBED THE SURGEON'S THUMB. WHEN WITHDRAWING HER HAND, THE METAL PIECE WAS STUCK IN HER THUMB, WENT THROUGH TWO GLOVES, AND PIERCED THE SURGEON'S SKIN. THE SURGEON WASHED AND DISINFECTED HER HAND AND THEN PROCEEDED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO PATIENT HARM. THERE WAS A CASE DELAY OF 45 SECONDS, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ON 4/16/2024, THE SALES REPRESENTATIVE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION VIA PHONE: AN AR-8944S-0R MAXFORCE MTP PLATE AND AN AR-9944S-0R VAL KREULOCK

  Patient problems: Exposure to Body Fluids

  MAUDE report 19316253 ↗
• MalfunctionSep 19, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT A AR-9944S-0R MTP COMPRESSION PLATE SNAPPED IN HALF AFTER BEING IMPLANTED 6 WEEKS AGO. THIS WAS DISCOVERED ON (B)(6) 2022 DURING AN UNSPECIFIED TIME. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 15445982 ↗