Arthrex® AR-8943-42Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867052499), received between May 3, 2017 and Jul 16, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE FRACTURE SURGERY THE DRILL BROKE OFF. EVERY BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT THE SURGEON WAS DRILLING AT AN AWKWARD ANGLE AND PUTTING A LOT OF PRESSURE ON THE DRILL AS IT WAS BENDING. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750425 ↗
• MalfunctionMay 13, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT FROM THE LOAN POSITION VK-14261-CALC-FX-PL // 404963018 TWO INSTRUMENTS WERE NOT USABLE. THESE ARE THE ARTICLES AR-8954-07+ AR-8943-42 FROM THE DLS-CALC-FX-PL-IN / 10151881. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299708 ↗
• MalfunctionMar 6, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-8943-42 DRILL BIT BROKE. THIS OCCURRED DURING A CASE ON (B)(6) 2023, WITH NO FRAGMENTS LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16485089 ↗
• MalfunctionFeb 28, 2022Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE DEVICE WAS DEFECT. THE DEVICE BROKE INSIDE THE PATIENT AND ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620658 ↗
• InjuryJul 31, 2019Break; Entrapment of Device

  IT WAS REPORTED DURING A PROCEDURE AS THE SURGEON WAS USING THE AR-8943-42, 2.5 MM DRILL BIT TO DRILL THE PILOT HOLE THROUGH THE DRILL GUIDE FOR THE PERCUTANEOUS CALCANEUS PLATE, THE TIP OF THE DRILL BROKE LEAVING APPROXIMATELY 3 CM IN THE BONE. THE REP STATED THE BROKEN PIECE COULD NOT BE RETRIEVED. THE CASE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 07/16/2019: THE PROCEDURE TAKING PLACE WAS A CALCANEUS FX PROCEDURE. THE REP STATED THERE WERE NOT ANY ATTEMPTS MADE TO REMOVE THE BROKEN FRAGMENT. THE SURGEON TOOK AN X-RAY AND IT WAS DISCOVERED THAT THE DRILL BIT WAS BELOW THE BONE AND PLATE. TWO OR THREE SCREWS WERE ALREADY IN THE PLATE BY THIS TIME. THE SURGEON LEFT THE BROKEN DRILL BIT PIECE IN CALCANEUS AND FILLED THE REMAINING SCREW HOLES. THERE IS NOT A PLAN TO PERFORM A REVISION/REMOVAL PROCEDURE AT THIS TIME, AND THERE ARE NOT ANY AVAILABLE PICTURES. THE DEVICE CAME WITHIN SET AR-8950S (LOT: 43900).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8845622 ↗
• InjuryJul 21, 2017Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A TALONAVICULAR FUSION PROCEDURE, THE SURGEON DRILLED THE FIRST LOCKING HOLE AND THEN DRILLED THE SECOND LOCKING HOLE. THERE IS A POSSIBILITY THAT THE SECOND LOCKING HOLE WAS IN TRAJECTORY OF THE K-WIRE HOLDING ARTHRODESIS SITE TOGETHER. THE SURGEON HAD A BIT OF DIFFICULTY USING THE 2.5 MM DRILL BIT ON THE SECOND HOLE, BUT EVENTUALLY PLUNGED THROUGH WHAT HE THOUGHT WAS THE FAR CORTEX. DEPTH GAUGE WAS DIFFICULT TO PLACE THROUGH THE MEDIAL HOLE (SECOND LOCKING HOLE DRILLED) BUT EVENTUALLY GOT DEPTH. TWO LOCKING SCREWS WERE PLACED, FOLLOWED BY TWO NON-LOCKING SCREWS. THE BIO WAS STABILIZED BY THE LOCKING GUIDE WHICH MADE THE BREAKAGE VERY SUSPECT AND UNNOTICED UNTIL FLUORO WAS USED FOR THE FINAL IMAGE. CASE WAS FINISHED AS BOOKED, ALTHOUGH THE 2 CM PIECE OF 2.5 MM DRILL BIT IS NOW IN THE CUBOID AND POSSIBLY THE SUBTALAR JOINT. THE REP IS NOT SURE IF PATIENT WILL NEED A SECOND SURGERY AND WILL BE FOLLOWING UP WITH THE SURGEON.

  Patient problems: Foreign Body In Patient

  MAUDE report 6731383 ↗
• InjuryMay 9, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A TRIPLE ARTHRODESIS PROCEDURE, THE SURGEON WAS DRILLING INTO THE PATIENT'S TALUS WITH A 2.5MM CALIBRATED DRILL BIT. WHILE DRILLING INTO THE TALUS FOR A 3.5 NON-LOCKING CORTICAL SCREW, THE DRILL TIP BROKE-OFF. THE TIP (1 CM) OF THE DRILL WAS UNABLE TO BE RETRIEVED. THE SURGEON RE-DRILLED IN A NEW TRAJECTORY TO PLACE THE 3.5 NON-LOCKING CORTICAL SCREW.

  Patient problems: No Information

  MAUDE report 6555582 ↗
• InjuryMay 3, 2017Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ANKLE FRACTURE REPAIR PROCEDURE, THE SURGEON WAS DRILLING THROUGH THE TIBIA WITH A 2.5MM CALIBRATED DRILL BIT. AS HE RETRACTED THE DRILL BIT, HE NOTICED THAT THE TIP OF THE DRILL BIT WAS GONE. ANOTHER INCISION WAS MADE ABOUT AN INCH PROXIMAL TO THE INCISION MADE FOR THE MEDIAL MAL AND THE DRILL BIT WAS TUNNELED OUT OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6539868 ↗