Arthrex® AR-8943BL-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867052512), received between Jan 27, 2020 and Apr 20, 2021 — classified as 1 injury, 1 malfunction.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON/SCRUB TECH DID NOT REALIZE THEY WERE USING A CANNULATED DRIVER AND CROSS THREADED THE LOCKING SCREW INTO THE PLATE. THE TORQUE ON THE DRIVER BROKE THE DRIVER AND THE SCREW AND THEY WERE UNABLE TO GET THE SCREW OUT OF THE PLATE. ADDITIONAL INFORMATION 4/9/2021: IT WAS REPORTED THAT DURING AN ANKLE FRACTURE REPAIR PROCEDURE, THE SURGEON/SCRUB TECH DID NOT REALIZE THEY WERE USING A CANNULATED DRIVER AND CROSS THREADED THE LOCKING SCREW INTO THE PLATE. THE IMPLANT SCREW WAS CROSS THREADED INTO THE PLATE AND THE WHOLE THING PULLED OUT OF THE PATIENT¿S BONE. THE TORQUE ON THE DRIVER BROKE THE DRIVER AND THE SCREW AND THEY WERE UNABLE TO GET THE SCREW OUT OF THE PLATE. THE CASE WAS COMPLETED USING A NEW PLATE, SCREW AND DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 11692724 ↗
• InjuryJan 27, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ORIGINAL ANKLE PROCEDURE (B)(6) 2017. DURING THE SURGERY SIX ARTHREX PRODUCTS WERE IMPLANTED. THE PATIENT DEVELOPED ALLERGIC LIKE REACTION SYMPTOMS AND RECENTLY HAD TO UNDERGO A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT THE ARTHREX DEVICES. PATIENT DID NOT HAVE AN FURTHER DETAILS AT THE TIME OF REPORT BUT WILL PROVIDE SOON. ADDITIONAL INFORMATION 1/8/2020: ORIGINAL PROCEDURE WAS ON (B)(6) 2017 AND WAS A LEFT ANKLE ORIF. FOLLOWING SURGERY THE PATIENT WAS IN THE HOSPITAL FOR THREE NIGHTS. SHE STARTED HAVING RINGING IN HER EARS AND DIZZINESS 3 MONTHS AFTER SURGERY. THIS WAS FOLLOWED BY TIREDNESS, MIGRAINES, AND TMJ ON HER RIGHT SIDE. SHE ALSO DEVELOPED NOTICEABLY DRIER, FLAKY SKIN AND MORE ANXIETY AFTER ABOUT 6 MONTHS. SHE DEVELOPED FOOD INTOLERANCE TO DAIRY AND DEVELOPED A THYROID NODULE AS WELL. PATIENT HAD A SECOND SURGERY ON (B)(6) 2019 TO EXPLANT ALL OF THE ORIGINAL IMPLANT DEVICES. THE SECOND SURGERY WAS PERFORMED BY A DIFFERENT SURGEON AT A DIFFERENT FACILITY. THE FOLLOWING DEVICES WERE REPORTED TO HAVE BEEN IMPLANTED ON (B)(6) 2017 AND EXPLANTED ON (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): AR-8926SS, KNOTLESS T

  Patient problems: Dizziness; Fatigue; Headache; Tinnitus

  MAUDE report 9631382 ↗