Arthrex® AR-8943-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867052208), received between Sep 21, 2021 and Sep 8, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670834 ↗
• MalfunctionOct 31, 2024Material Separation; Material Separation

  ON 10/15/2024, IT WAS REPORTED BY A DISTRIBUTOR VIA (B)(4) THAT AN AR-8943-10 SCREWDRIVER'S BLACK AND YELLOW STRIPES WERE PEELING. THIS OCCURRED DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2024 WHEN IT WAS NOTICED THE PEELING AND THE DRIVER WAS CONSIDERED UNACCEPTABLE TO USE FOR SURGERY ACCORDING TO THE STERILE PROCESSING DEPARTMENT. ANOTHER SCREWDRIVER WAS AVAILABLE AND USED FOR THE SURGERY. NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577859 ↗
• InjuryJul 2, 2024Break; Break

  ON 6/3/2024, IT WAS REPORTED BY A PATIENT VIA EMAIL THAT AN AR-8943-10 T15 HEXALOBE SCREWDRIVER BROKE DURING A PROCEDURE AND WAS LEFT IN THE PATIENT. THE PATIENT IS EXPERIENCING A POTENTIAL ALLERGIC REACTION AND HAS REQUESTED THE MATERIAL COMPOSITION OF THE SCREWDRIVER. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED ON 6/4/2024: THE PATIENT REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ACL, LET, MEDIAL MENISCECTOMY, AND LATERAL MENISCAL REPAIR PROCEDURE. DURING THE PROCEDURE, THE SURGEON USED THE SCREWDRIVER IN AN ATTEMPT TO REMOVE HARDWARE FROM A POSTEROLATERAL CORNER SURGERY PERFORMED ON (B)(6) 2011. THE ATTEMPT FAILED WHEN THE TIP OF THE SCREWDRIVER BROKE IN THE SCREW. TWELVE OTHER INSTRUMENTS WERE THEN USED IN THE REMOVAL EFFORTS, BUT WERE UNSUCCESSFUL. ALTERATIONS WERE MADE TO THE SURGICAL PLAN, AND THE SURGEON PROCEEDED TO LEAVE THE TIP OF THE SCREWDRIVER IN WITH THE STUCK SCREW. NO OTHER COMPLICATIONS WERE NOTED DURING THE SURGERY. THE PATIENT IS EXPERIENCING SKIN REACTION TO THE SURGICAL DRESSING, CONTINUED INCREASE IN OVERALL SKIN SENSITIVITY, NEW ONSET CIRCULATION ISSUES, DIFFICULTY STAYING WARM EVEN IN WARM ENVIRONMENTS, NUMBNESS OF HA

  Patient problems: Foreign Body In Patient; Hypersensitivity/Allergic reaction

  MAUDE report 19656126 ↗
• MalfunctionSep 21, 2021Material Integrity Problem

  IT WAS REPORTED THE BELOW INSTRUMENT NEED TO BE REPLACED. QTY(1) AR-9623 ¿ THREADED, QTY(1) AR-8943-10 ¿ TORQUED. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: Insufficient Information

  MAUDE report 12506022 ↗