Arthrex® AR-8827L-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867047099), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

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

• InjuryJun 27, 2019Fracture; Labelling, Instructions for Use or Training Problem; Use of Device Problem

  IT WAS REPORTED DURING A PRIMARY PERCUTANEOUS PROCEDURE THAT TOOK PLACE ON (B)(6) 2019, THE SURGEON WAS ATTEMPTING TO PUT A SONOMA 3.5 X 55 (CO3555DS / LOT: A17111705 ) SCREW INTO THE AR-8973L-30-130 FIBULA NAIL (LOT: 10297815), BUT THE SCREW WOULD NOT LINE UP AND THE SURGEON COULD NOT GET THE RIGHT TRAJECTORY. THE SURGEON WAS ABLE TO ACHIEVE GOOD FIXATION WITHOUT USING THE SCREW. THE FIBULA NAIL WAS LEFT IMPLANTED, AND THE CASE WAS COMPLETED SUCCESSFULLY. THE PATIENT CAME IN FOR A FOLLOW UP VISIT ON (B)(6) 2019 AND DURING THE FOLLOW-UP VISIT IT WAS DISCOVERED THAT THE PATIENT AMBULATED ON THE NAIL POST-OPERATIVELY AND RE-FRACTURED THEIR FIBULA. A REVISION/REMOVAL PROCEDURE TOOK PLACE ON (B)(6) 2019, AND WAS PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY. DURING THE REVISION PROCEDURE, THE AR-8973L-30-130 WAS SUCCESSFULLY REMOVED. UPON REMOVAL, IT WAS DISCOVERED THAT THE DEVICE IS LABELED AS AN AR-8973L-30-130 (LEFT) NAIL, BUT THE DEVICE IS ACTUALLY A RIGHT NAIL. THE NAIL WAS REINSERTED ON THE JIG, AND UPON FURTHER INVESTIGATION ALL HOLES LINED UP AS A RIGHT NAIL. IT WAS ALSO DISCOVERED THAT THE LOT NUMBER ETCHED ON THE DEVICE IS DIFFERENT THAN THE LOT NUMBER THAT WAS ON THE OR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8739503 ↗