Arthrex® AR-8827L-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867047037), received between Jun 21, 2018 and May 22, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 19376170 ↗
• 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 (B)(6) 2017 AND EXPLANTED (B)(6) 2019 (SPECIFIC ARTHREX PART NUMBERS WERE NOT PROVIDED): (B)(4), KNOTLESS TIGHTROPE

  Patient problems: Anxiety; Dizziness; Fatigue; Headache; Reaction; Tinnitus

  MAUDE report 9631383 ↗
• InjuryJun 21, 2018Migration or Expulsion of Device; Mechanics Altered

  IT WAS REPORTED THAT DURING A REVISION LT ANKLE FX PROCEDURE A TOTAL OF QTY. 3 AR-8827L-12 (LOT: 031731, LOT: 10158067, LOT: 185363) AND QTY. 2 AR-8827L-14 (LOT: 031725) WOULD NOT STAY ENGAGED IN THE PLATE. THE BONE WAS PREPPED BY A 2.0MM DRILL. ADDITIONAL INFORMATION RECEIVED 6/12/2018: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2017. THE TYPE OF PROCEDURE BEING PERFORMED WAS A FIBULA FX. THE CASE TOOK PLACE AT (B)(6) HOSPITAL AND THE SURGERY WAS PERFORMED BY DR. (B)(6). THE FOLLOWING ARTHREX PART NUMBERS WERE IMPLANTED DURING THE (B)(6) 2017 PROCEDURE (LOT NUMBERS OF THE DEVICES ARE UNKNOWN). AR-8943BL-05. AR-8835-12 (QTY. 2). AR-8830-14 (QTY. 1). AR-8835-14 (QTY. 1). AR-8827L-14 (QTY. 3). AR-8827L-10 (QTY. 1). THE REVISION SURGERY TOOK PLACE ON (B)(6) 2018 TO FIX A HIGH NON UNION FIBULA FX. IT IS UNKNOWN IF OR WHAT SPECIFIC PART AND LOT NUMBERS WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. DURING THE REVISION SURGERY, A 2.7 LOCKING GUIDE WAS PLACED INTO THE LOCKING HOLE. THE BONE WAS DRILLED WITH A 2MM DRILL. A QUANTITY OF 3 AR-8827L-12, LOW PROFILE LOCKING SCREW(S) (LOT: 031731/LOT: 10158067/LOT: 185363) WOULD NOT FULLY ENGAGE INTO THE FIBULA PLATE. THE SURGEON BACKED

  Patient problems: No Code Available

  MAUDE report 7625272 ↗