Arthrex® AR-8944DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867053045), received between Jul 11, 2022 and Dec 16, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8944DH DRIVER TIP WAS TWISTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED ON 12/2/2025: IT WAS FURTHER REPORTED THAT THIS OCCURRED DURING A CLAVICLE FRACTURE PROCEDURE, AND THE CASE WAS COMPLETED WITH ANOTHER DRIVER. NO PATIENT HARM OR CASE DELAY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817023 ↗
• MalfunctionJun 20, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 05/29/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8944DH DRIVER IS BENT AT THE TIP. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296772 ↗
• MalfunctionJul 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE DEVICE IS BENT AND DAMAGED. THE PROBLEM WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATED CASE (B)(4) 09-JUL-2024. IT WAS REPORTED THAT DURING A SURGERY THE DRIVER WAS BENT AND DAMAGED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE FROM ANOTHER COMPANY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761803 ↗
• MalfunctionJun 27, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A MTP FUSION SURGERY THE THREADS TURNED ON THIS DRIVER DUE TO FORCE WHEN INSERTING THE SCREW. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19623832 ↗
• MalfunctionJun 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING AN MTP ARTHRODESIS THE SCREWDRIVER ATTACHMENT BENT AND THE COMPRESSION INSTRUMENT IS BENT AND HAD BROKEN-OFF PRONGS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY AND THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 12-APR-2023 NEN: FURTHER INFORMATION REVEALED THAT THE DEVICES WERE DAMAGED INSIDE THE PATIENT. THE SURGEON CANNOT CONFIRM THAT NO PARTICLES ARE MILLED OFF WHEN SCREWING IN. FOR THIS REASON, THE WOUND WAS RINSED TO ENSURE THAT NOTHING REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19521070 ↗
• MalfunctionJan 17, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 12/22/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-8944DH T10 HEXALOBE DRIVER TWISTED WHILE SCREWING IN THE IMPLANT. THE CASE WAS COMPLETED SUCCESSFULLY USING A SECOND DRIVER. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528428 ↗
• MalfunctionOct 24, 2023Break; Break

  ON 9/25/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-8944DH T10 HEXALOBE DRIVER TIP BROKE OFF IN A DISTAL LOCKING SCREW HEAD. THE TIP WAS ABOUT 2MM, AND IT COULD NOT BE REMOVED FROM THE HEAD OF THE SCREW. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17995120 ↗
• MalfunctionNov 7, 2022Break; Difficult to Remove

  ON 10/18/2022, IT WAS REPORTED BY MEDWATCH VIA EMAIL THAT AN AR-8944DH DRIVER TIP BROKE IN THE HEAD OF THE SCREW. BROKEN PIECE WAS UNABLE TO BE RETRIEVED. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 15743272 ↗
• MalfunctionOct 11, 2022Break

  IT WAS REPORTED ON (B)(6) 2022 BY A SALES REPRESENTATIVE VIA EMAIL VIA MEDWATCH THAT AN AR-8944DH DRIVER HEAD BROKE OFF INSIDE THE SCREW AND WAS UNABLE TO BE RETRIEVED. THIS WAS DISCOVERED DURING A CASE AND BROKE OFF INSIDE THE JOINT SPACE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15576218 ↗
• MalfunctionSep 22, 2022Break

  TIP OF ARTHREX SCREW DRIVER TIP BROKE OF IN HEAD OF SCREW. UNABLE TO RETRIEVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15462262 ↗
• MalfunctionJul 11, 2022Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN ANKLE JOINT SURGERY THE DEVICE TWISTED. A PART OF THE DEVICE BROKE OFF INSIDE THE PATIENT, BUT ALL FRAGMENTS WERE RETRIEVED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 21-JUN-2022 IT WAS CONFIRMED THAT NO PART OF THE DEVICE BROKE OFF AND REMAINED INSIDE THE PATIENT. DURING UNSCREWING, TOO MUCH FORCE WAS USED. THEREFORE THE DEFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976733 ↗