Arthrex® AR-8944CL-LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867052888), received between Jun 9, 2017 and Apr 25, 2022 — classified as 2 injuries, 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 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.

• MalfunctionApr 25, 2022Break

  THE PATIENT HAD SURGERY ON THE JOINT OF HER LEFT BIG TOE ON THE (B)(6) 2020, WHICH WAS REMOVED AND REPLACED WITH A METAL PLATE AND SCREW. THE PATIENT RETURNED TO WORK ON THE (B)(6) 2021 WITH CLEARANCE FROM THE SURGEON. ON THE (B)(6) 2021, AROUND 2 PM AFTER LUNCH, THE PATIENT WAS WALKING UP THE STAIRS BACK TO THE LAB WHEN SHE FELT A PAIN IN THE BALL OF HER LEFT FOOT. WHEN SHE REACHED THE TOP OF THE STAIRS, IT WAS HARD TO BEAR WEIGHT (THIS WAS DAY 79 AFTER THE OPERATION). ON THE (B)(6) 2021, SHE WENT TO WORK AND AT 9 AM, SHE PHONED THE SURGEON'S ROOM TO LET THEM KNOW SHE WAS IN PAIN. SHE WAS ASKED TO GO AND GET AN X-RAY THAT MORNING WHICH SHE DID, AND THEN WENT BACK TO WORK FOR THE REST OF THE DAY. ON THE (B)(6) 2021, SHE WENT TO WORK UNTIL 10.15 AM AND THEN TO THE SURGEON'S ROOM FOR AN URGENT APPOINTMENT. THE SURGEON LOOKED AT HER TOE, BENT SEVERELY TO THE LEFT AND SWOLLEN. THE SURGEON MENTIONED TO THE PATIENT THAT IT DIDN'T LOOK GOOD. THE PATIENT AND THE SURGEON LOOKED AT THE X-RAY. IT SHOWED THE PLATE HAD BROKEN TOWARDS THE TOP. THE SURGEON SAID IT WAS AN UNUSUAL SPOT TO BREAK.

  Patient problems: Pain

  MAUDE report 14195466 ↗
• InjuryMar 5, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A LEFT 1ST METATARSOPHALANGEAL JOINT REVISION FUSION AND HARDWARE REMOVAL, EXTRACTION OF GRAFT AND WEIL OSTEOTOMY ON (B)(6) 2017 DUE TO PAINFUL NONUNION OF HER LEFT FIRST METATARSOPHALANGEAL JOINT FUSION. DURING THE PROCEDURE THE SURGEON EXPLANTED A PLATE AND LAG SCREWS FROM A PREVIOUS PROCEDURE (DATE OF PREVIOUS PROCEDURE AND EXPLANTED DEVICE MANUFACTURER UNKNOWN AT TIME OF INITIAL REPORT). THE SURGEON UTILIZED A 1.7 MM DRILL BIT, AR-1201-7DC, FOR MICRO DRILLING THROUGH THE FUSION SITE IN ORDER TO PROMOTE INGROWTH AND THE DRILL BIT SNAPPED OFF INTRAMEDULLARY. THE SURGEON ATTEMPTED TO REMOVE THE DRILL BIT FRAGMENT BUT WAS UNABLE TO BECAUSE OF THE LOCATION. THE OPERATIVE REPORT DATED (B)(6) 2017 NOTED THAT REMOVAL OF THE DRILL BIT FRAGMENT WOULD CAUSE MORE HARM TO THE PATIENT. THE SURGEON FINISHED THE SURGERY BY PERFORMING A CAPSULOTOMY AND WEILL OSTEOTOMY AND IMPLANTED THE FOLLOWING ARTHREX PLATE AND SCREWS: AR-8944CL-L (LOW PROFILE MTP PLATE), AR-8730-38PT (QUICKFIX SCREW), AR-8933-24 (LOW PROFILE SCREW), AR-8933-18 (LOW PROFILE SCREW), AND AR-8933L-18 (QTY 2) (LOW PROFILE LOCKING SCREW). IN (B)(6) 20

  Patient problems: Device Embedded In Tissue or Plaque; Necrosis; Pain

  MAUDE report 8391590 ↗
• InjuryJun 9, 2017Fracture

  IT WAS REPORTED IN THE COMPLAINT SERVED ON ARTHREX ON (B)(6) 2017, AND RECEIVED (B)(6) 2017, THAT ON (B)(6) 2015 THE CLAIMANT (PATIENT) WAS TREATED FOR A LEFT HALLUX VALGUS DEFORMITY OF THE LEFT 1ST METATARSOHALANGEAL JOINT (MTPJ) WITH JOINT FUSION. ARTHREX'S INTERNAL FIXATION PLATE, AR-8944-CL-L (LOT UNKNOWN) WAS USED AND PLACED ACROSS THE MTPH. THE PLATE WAS REPORTED TO HAVE FRACTURED BY (B)(6) 2016. ON (B)(6) 2016 THE CLAIMANT UNDERWENT SURGERY FOR REMOVAL OF THE PLATE FROM HIS LEFT FOOT. FACILITY INFORMATION AND ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6629192 ↗