Arthrex® AR-8944-22Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867052840), received between Jun 26, 2019 and Jun 4, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Break

  IT WAS REPORTED THAT DURING A LISFRANC SURGERY THE DRILL BIT BROKE. ALL PARTS COULD BE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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. UPDATE 01-JUN-2026: THE CUSTOMER CONFIRMED THAT THEY USED THE DEVICE MULTIPLE TIMES, EVEN THOUGH IT IS A SINGLE USE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25390620 ↗
• MalfunctionMar 4, 2024Break; Break

  ON THE 15TH FEBRUARY 2024 IT WAS ADVISED BY A SALES REP THAT AN AR-8944-22, (DRILL BIT, 2.0 MM) - BATCH# UNKNOWN WAS REPORTED AS THE SURGEON WAS USING THE 2MM DRILL AND IT SNAPPED OFF INSIDE THE DRILL HOLE WHEN DRILLING TO INSERT A 3MM CORTEX SCREW IN A MAXFORCE PLATE. THERE WAS A CASE AND PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18826105 ↗
• MalfunctionJun 20, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (QTY. 2) OF AN AR-8944-22 DRILL BIT BROKE DURING A CASE WITH A SLIGHT CASE DELAY OF APPROXIMATELY 5 MINUTES TO RETRIEVE ANOTHER BIT. THE DEVICE BROKE WITHIN THE PATIENT, BUT THEY COULD RETRIEVE ALL FRAGMENTS AND COMPLETE THE PROCEDURE. ONE OF THE INCIDENTS HAPPENED YESTERDAY, AND ANOTHER WITH A DIFFERENT SURGEON TODAY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED ON 6/31/2023: THIS WAS DISCOVERED DURING A PATELLA TENDON RECONSTRUCTION PROCEDURE ON (B)(6) 2023. THE AR-8944-22 DRILL BIT BROKE WHEN DRILLING TUNNELS. THE CASE WAS COMPLETED BY OPENING A STERILE 2.0 DRILL NON-ARTHREX PRODUCT. THERE WERE NO PICTURES TAKEN OF THE DEVICE..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161594 ↗
• InjuryJun 26, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THE TIP OF THE AR-8944-22 DRILL BIT (APPROXIMATELY 15-20MM) BROKE OFF WHILE IN BONE DURING A LAPIDUS PROCEDURE. THE REP STATED THE BROKEN PIECE WAS NOT NOTICED UNTIL FINAL X-RAYS WERE BEING TAKEN. THE REP STATED THEY HAD ALREADY LEFT THE OR, BUT RETURNED TO THE ROOM ONCE NOTIFIED. THE BROKEN FRAGMENT REMAINS IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 06/17/2019: THE REP STATED IT IS UNKNOWN IF THE SURGEON PLANS TO PERFORM A REVISION SURGERY TO REMOVE THE FRAGMENT. THE PROCEDURE WAS OPEN, AND THERE ARE NOT ANY PORTIONS OF THE DRILL BIT AVAILABLE TO RETURN FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 06/18/2019: THE REP REPORTED THAT THE SURGEON DOES NOT CURRENTLY PLAN ON PERFORMING A SECOND SURGERY. THEY WILL CONTINUE TO MONITOR. A COPY OF THE X-RAY HAS BEEN PROVIDED TO ARTHREX.

  Patient problems: Foreign Body In Patient

  MAUDE report 8735136 ↗