Arthrex® AR-8750KTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888867263649), received between Feb 26, 2020 and Jan 30, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionJan 30, 2023Break; Entrapment of Device; Difficult to Insert; Difficult to Remove; Material Twisted/Bent

  ON 1/12/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA MEDWATCH EMAIL THAT AN AR-8750KT GUIDE WIRE WITH TROCAR TIP BROKE OFF IN THE PATIENT'S RIGHT ANKLE. THE PIN LIKELY BENT WHILE IT WAS BEING INSERTED AND THEREFORE WHEN IT WAS REMOVED, THE TIP BROKE OFF. THE SURGEON ATTEMPTED TO REMOVE THE BROKEN PIECE BUT WAS UNSUCCESSFUL AFTER SEVERAL HOURS. SURGEON DETERMINED THAT IF THE JOINT WAS TO BE REOPENED, IT WOULD HAVE POTENTIALLY CAUSED MORE HARM BY DAMAGING THE REPAIR THAT WAS ALREADY COMPLETED. PER SURGEON, AFTER 10 WEEKS POST OPERATIVE, TO LET THE REPAIR TO HEAL, A REVISION SURGERY CAN TAKE PLACE TO REMOVE THE PIN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 16263941 ↗
• InjuryMar 9, 2020Break

  IT WAS REPORTED THAT DURING A SUBTALAR FUSION PROCEDURE, THE SURGEON BROKE THE THREADED TIP OF AR-8750KT INSIDE THE PATIENT¿S TALUS. NO ATTEMPT WAS MADE TO RETRIEVE. THE SURGEON WAS ATTEMPTING TO CHANGE THE POSITION OF THE K WIRE AND WHILST DRILLING OUT ON FORWARD THE TIP WAS ADVANCING WHILST THE SHAFT OF THE K WIRE WAS BEING WITHDRAWN FROM THE PATIENT, HENCE A BREAKAGE IS POSSIBLE. IN THE SAME CASE THE SURGEON INSERTED A NEW AR-8750KT SUCCESSFULLY. HOWEVER, BROKE AN AR-8750-40H INSIDE THE PATIENT. THE SURGEON IS VERY FAMILIAR WITH THIS SYSTEM AND ALL ASPECTS OF THE INSERTION APPEARED TO BE COMPLETED CORRECTLY. SURGEON CONTINUED TO INSERT SCREW EVEN AFTER CONSIDERABLE RESISTANCE WAS ENCOUNTERED; HE DIDN¿T STOP TO REMOVE THE SCREW AND RE-DRILL OR ALTER APPROACH. THE SURGEON DRILLED WITH THE CORRECT 1.6 MM GUIDE WIRE (AR-8750KT), MEASURED WITH DEPTH DEVICE (AR-8750-01), OVER DRILLED WITH 3.2 MM DRILL BIT (AR-8750-09), HAND POWERED PROFILE DRILL (AR-8750-05), INSERTED SCREW BY HAND SCREW DRIVER (AR-8750-03) AND THEN FINISHED WITH SOLID DRIVER (AR-8750-06). THE SURGEON DEMANDED THE SOLID DRILL AFTER TWISTING/WARPING THE END OF THE CANNULATED DRIVER AFTER EXCESSIVE TORSIONAL FORCE DURIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9805163 ↗
• InjuryFeb 26, 2020Break

  IT WAS REPORTED DURING A LAPIDUS FUSION AND A MEDIALIZING CALCANEAL OSTEOTOMY PROCEDURE THE TIPS OF THE AR-8737-42 GUIDE WIRE TROCAR TIP WITH LASER LINE, AND AR-8750KT GUIDE WIRE WITH TROCAR TIP BROKE OFF WHERE THE THREADS START. THE REP REPORTED THE BROKEN TIPS WERE SO SMALL THAT THEY COULD NOT BE RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9756800 ↗