Arthrex® AR-8771-0422XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867339897), received between Oct 12, 2021 and May 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMay 9, 2024Device Damaged by Another Device; Device Damaged by Another Device

  ON 7/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-8771-0422X DYNANITE COMPRESSION PLATE WAS IMPLANTED WITHOUT ANY ISSUES. AFTER THE PLATE WAS SECURE WITH FOUR 3.0MM HYBRID LOCKING SCREW, A T10 SCREW DRIVER WAS USED TO REMOVE THE COMPRESSION DEVICE. HOWEVER, THE SCREW IMMEDIATELY STRIPPED AND HAD METAL SHAVING COME OUT, IMPEDING THE DRIVER FROM ENGAGING AGAIN. SURGEON ATTEMPTED TO USE PLIERS TO TURN THE SCREW COUNTER CLOCKWISE AND ENGAGE THE COMPRESSION DEVICE, BUT THE SCREW WOULD NOT BUDGED. THIS WAS DISCOVERED DURING A TALAR-NAVICULA ARTHRODESIS PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 7/14/2022: SURGEON HAD TO REMOVE THE ENTIRE COMPRESSION PLATE ALONG WITH THE SCREWS AND USE A NEW AR-8771-0422X DYNANITE COMPRESSION PLATE, FROM LOT 13434733, ALONG WITH THE SAME SCREWS FROM THE PREVIOUS PLATE, TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19280102 ↗
• MalfunctionMay 27, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-8771-0422X DYNANITE COMPRESSION PLATE WAS IMPLANTED ON PATIENT DURING A TARSAL METATARSAL FUSION PROCEDURE ON (B)(6) 2021. ON (B)(6) 2022, IT WAS NOTICED TO BE BROKEN VIA X-RAY. PATIENT UNDERWENT TARSAL METATARSAL FUSION REVISION SURGERY ON (B)(6) 2022 AND HAD THE AR-8771-0422X DYNANITE COMPRESSION PLATE ALONG WITH THE STAPLES FROM AN AR-8719DS-181815 DYNANITE NITINOL STAPLE IMPLANT SYSTEM REMOVED. SURGEON COMPLETED THE REVISION SURGERY BY IMPLANTING DEVICES FROM ANOTHER MANUFACTURER. CASE WAS COMPLETED SUCCESSFULLY AND NO FURTHER ISSUES HAS BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14523306 ↗
• InjuryOct 12, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-8771-0422X DYNANITE COMP PLATE AND AN AR-8771-0427X DYNANITE COMP PLATE BROKE POST-OPERATIVE. THE DATE OF THE PRIMARY PROCEDURE WAS (B)(6) 2020 FOR A TN AND CC FUSION. THIS PROCEDURE TOOK PLACE AT (B)(6) HOSPITAL, ARTHREX ACCOUNT # (B)(4). DATE OF REVISION IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12616469 ↗